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Completed

NCT Number: NCT03815175

XIENCE 28 USA Study

The XIENCE 28 USA Study is prospective, single arm, multi-center, open label, non-randomized trial to evaluate safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family (XIENCE Xpedition Everolimus Eluting Coronary Stent System [EECSS], XIENCE Alpine EECSS and XIENCE Sierra EECSS) of coronary drug-eluting stents.

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Key information

Conditions

Bleeding Disorder Anemia Arterial Occlusive Diseases Arteriosclerosis Blood Platelet Disorders Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coagulation Disorder Coronary Artery Disease Coronary Disease Cytopenia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Hematologic Diseases Hematological Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemorrhagic Stroke Hemostatic Disorders Ischemic Stroke Kidney Diseases Male Urogenital Diseases Myocardial Ischemia Nervous System Diseases Renal Insufficiency Stroke Thrombocytopenia Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kepler Universitätsklinikum GmbH, Linz, UPR AUS, Austria

Loading trial locations.

About this study

The XIENCE 28 USA Study will evaluate the safety of 1-month DAPT following XIENCE implantation in HBR patients. A minimum of 640 to a maximum of 800 subjects will be registered from approximately 50 sites in the United States and Canada. Subject registration is capped at 75 per site. Eligibility of P2Y12 receptor inhibitor discontinuation will be assessed at 1-month follow-up. Subjects who are free from myocardial infarction (MI), repeat coronary revascularization, stroke, or stent thrombosis (ARC definite/probable) within 1 month (prior to 1-month visit but at least 28 days) after stenting AND have been compliant with 1-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days are considered as "1-month clear", and will discontinue P2Y12 receptor inhibitor as early as 28 days and continued with aspirin monotherapy through 12-month follow-up.

All registered subjects will be followed at 1, 3, 6 and 12 months post index procedure. The data collected from the XIENCE 28 USA Study will be pooled with the data from the XIENCE 28 Global Study (Protocol # ABT-CIP-10235) to compare with the historical control of non-complex HBR subjects treated with standard DAPT duration of up to 12 months from the XIENCE V USA Study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is considered at high risk for bleeding (HBR), defined as meeting one or more of the following criteria at the time of registration and in the opinion of the referring physician, the risk of major bleeding with > 1-month DAPT outweighs the benefit:
  • ≥ 75 years of age.
  • Clinical indication for chronic (at least 6 months) or lifelong anticoagulation therapy
  • History of major bleeding which required medical attention within 12 months of the index procedure.
  • History of stroke (ischemic or hemorrhagic).
  • Renal insufficiency (creatinine ≥ 2.0 mg/dl) or failure (dialysis dependent).
  • Systemic conditions associated with an increased bleeding risk (e.g. hematological disorders, including a history of or current thrombocytopenia defined as a platelet count <100,000/mm3, or any known coagulation disorder associated with increased bleeding risk).
  • Anemia with hemoglobin < 11g/dl.
  • Subject must be at least 18 years of age.
  • Subject must provide written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site prior to any trial related procedure.
  • Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at 1 month, if eligible per protocol.
  • Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure, except for cases where subject is transferred to the XIENCE 90 study after the 1-month visit assessment

Angiographic Inclusion Criteria

  • Up to three target lesions with a maximum of two target lesions per epicardial vessel. Note:
  • The definition of epicardial vessels means left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX) and right coronary artery (RCA) and their branches. For example, the subject must not have >2 lesions requiring treatment within both the LAD and a diagonal branch in total.
  • If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion.
  • Target lesion must be located in a native coronary artery with visually estimated reference vessel diameter between 2.25 mm and 4.25 mm.
  • Exclusive use of XIENCE family of stent systems during the index procedure.
  • Target lesion has been treated successfully, which is defined as achievement of a final in-stent residual diameter stenosis of <20% with final TIMI-3 flow assessed by online quantitative angiography or visual estimation, with no residual dissection NHLBI grade ≥ type B, and no transient or sustained angiographic complications (e.g., distal embolization, side branch closure), no chest pain lasting > 5 minutes, and no ST segment elevation > 0.5mm or depression lasting > 5 minutes.

Exclusion criteria

  • Subject with an indication for the index procedure of acute ST-segment elevation MI (STEMI).
  • Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
  • Subject with implantation of another drug-eluting stent (other than XIENCE) within 12 months prior to index procedure.
  • Subject has a known left ventricular ejection fraction (LVEF) <30%.
  • Subject judged by physician as inappropriate for discontinuation from P2Y12 inhibitor use at 1 month, due to another condition requiring chronic P2Y12 inhibitor use.
  • Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 1 month following index procedure.
  • Subject with a current medical condition with a life expectancy of less than 12 months.
  • Subject intends to participate in an investigational drug or device trial within 12 months following the index procedure. Transferring to the XIENCE 90 study will not be an exclusion criterion.
  • Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
  • Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

Angiographic Exclusion Criteria

  • Target lesion is in a left main location.
  • Target lesion is located within an arterial or saphenous vein graft.
  • Target lesion is restenotic from a previous stent implantation.
  • Target lesion is a chronic total occlusion (CTO, defined as lesion with TIMI flow 0 for at least 3 months).
  • Target lesion is implanted with overlapping stents, whether planned or for bailout.

Treatment and study plan

Xience

Device

Subjects who received XIENCE family stent systems will be included.

DAPT (aspirin and/or P2Y12 receptor inhibitor)

Drug

"1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.

Other names: Dual antiplatelet therapy

Primary outcomes

  1. Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI) (Modified Academic Research Consortium [ARC]), by Propensity Score Quintile

    Time frame: From 1 to 6 months

    All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.

    MI Definition (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Peripheral MI
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

  2. Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile

    Time frame: From 6 to 12 months

    All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.

    MI Definition (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Peripheral MI
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

  3. Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile

    Time frame: From 1 to 12 months

    All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.

    MI Definition (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Peripheral MI
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

Secondary outcomes

  1. Percentage of Participants With Major Bleeding Rate (Bleeding Academic Research Consortium [BARC] Type 2-5), by Propensity Score Quintiles

    Time frame: From 1 to 6 months

    Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:

    • Type 2: Any overt, actionable sign of hemorrhage
    • Type 3a: Overt bleeding plus Hb drop of 3 to < 5g/dL;Any transfusion with overt bleeding
    • Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents
    • Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision
    • Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood/packed red blood cells within a 48h period;Chest tube output ≥ 2L within 24-h period
    • Type 5: Fatal bleeding
    • Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious
    • Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation

  2. Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles

    Time frame: From 6 to 12 months

    Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:

    • Type 2: Any overt, actionable sign of hemorrhage
    • Type 3a: Overt bleeding plus Hb drop of 3 to < 5g/dL;Any transfusion with overt bleeding
    • Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents
    • Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision
    • Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood/packed red blood cells within a 48h period;Chest tube output ≥ 2L within 24-h period
    • Type 5: Fatal bleeding
    • Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious
    • Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation

  3. Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles

    Time frame: From 1 to 12 months

    Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:

    • Type 2: Any overt, actionable sign of hemorrhage
    • Type 3a: Overt bleeding plus Hb drop of 3 to < 5g/dL;Any transfusion with overt bleeding
    • Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents
    • Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision
    • Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood/packed red blood cells within a 48h period;Chest tube output ≥ 2L within 24-h period
    • Type 5: Fatal bleeding
    • Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious
    • Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation

  4. Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)

    Time frame: From 1 to 6 months

    Definite stent thrombosis:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis:

    Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:

    • Any unexplained death within the first 30 days
    • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause

  5. Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)

    Time frame: From 6 to 12 months

    Definite stent thrombosis:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis:

    Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:

    • Any unexplained death within the first 30 days
    • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause

  6. Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)

    Time frame: From 1 to 12 months

    Definite stent thrombosis:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis:

    Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:

    • Any unexplained death within the first 30 days
    • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause

  7. Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)

    Time frame: From 1 to 6 months

    All Death:

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.

    Cardiac death:

    Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death:

    Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death:

    Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

  8. Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)

    Time frame: From 6 to 12 months

    All Death:

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.

    Cardiac death:

    Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death:

    Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death:

    Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

  9. Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)

    Time frame: From 1 to 12 months

    All Death:

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.

    Cardiac death:

    Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death:

    Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death:

    Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

  10. Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)

    Time frame: From 1 to 6 months

    All Myocardial Infarction (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Periprocedural MI:
    • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL
    • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

    TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.

  11. Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC)

    Time frame: From 6 to 12 months

    All Myocardial Infarction (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Periprocedural MI:
    • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL
    • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

    TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.

  12. Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC)

    Time frame: From 1 to 12 months

    All Myocardial Infarction (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Periprocedural MI:
    • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL
    • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

    TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.

  13. Number of Participants With Composite of Cardiac Death or MI (Modified ARC)

    Time frame: From 1 to 6 months

    Cardiac death:

    Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    MI (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Periprocedural MI:
    • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URLwith baseline value < URL
    • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

  14. Number of Participants With Composite of Cardiac Death or MI (Modified ARC)

    Time frame: From 6 to 12 months

    Cardiac death:

    Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    MI (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Periprocedural MI:
    • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URLwith baseline value < URL
    • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

  15. Number of Participants With Composite of Cardiac Death or MI (Modified ARC)

    Time frame: From 1 to 12 months

    Cardiac death:

    Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    MI (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Periprocedural MI:
    • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URLwith baseline value < URL
    • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

  16. Number of Participants With Composite of All Death or All MI (Modified ARC)

    Time frame: From 1 to 6 months

    All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.

    MI (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Periprocedural MI
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

  17. Number of Participants With Composite of All Death or All MI (Modified ARC)

    Time frame: From 6 to 12 months

    All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.

    MI (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Periprocedural MI
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

  18. Number of Participants With Composite of All Death or All MI (Modified ARC)

    Time frame: From 1 to 12 months

    All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.

    MI (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Periprocedural MI
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

  19. Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)

    Time frame: From 1 to 6 months

    An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.

    • Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.
    • Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.
    • Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.
    • Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)

  20. Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)

    Time frame: From 6 to 12 months

    An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.

    • Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.
    • Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.
    • Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.
    • Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)

  21. Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)

    Time frame: From 1 to 12 months

    An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.

    • Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.
    • Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.
    • Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.
    • Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)

  22. Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)

    Time frame: From 1 to 6 months

    Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.

    Clinically Indicated [CI] Revascularization:

    A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

    • A positive history of recurrent angina pectoris, presumably related to the target vessel;
    • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
    • Abnormal results of any invasive functional diagnostic test
    • A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

  23. Number of Participants With CI-TLR

    Time frame: From 6 to 12 months

    Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.

    Clinically Indicated [CI] Revascularization:

    A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

    • A positive history of recurrent angina pectoris, presumably related to the target vessel;
    • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
    • Abnormal results of any invasive functional diagnostic test
    • A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

  24. Number of Participants With CI-TLR

    Time frame: From 1 to 12 months

    Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.

    Clinically Indicated [CI] Revascularization:

    A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

    • A positive history of recurrent angina pectoris, presumably related to the target vessel;
    • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
    • Abnormal results of any invasive functional diagnostic test
    • A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

  25. Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)

    Time frame: From 1 to 6 months

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

    • A positive history of recurrent angina pectoris, presumably related to the target vessel;
    • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
    • Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve);
    • A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

  26. Number of Participants With CI-TVR

    Time frame: From 6 to 12 months

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

    • A positive history of recurrent angina pectoris, presumably related to the target vessel;
    • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
    • Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve);
    • A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

  27. Number of Participants With CI-TVR

    Time frame: From 1 to 12 months

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

    • A positive history of recurrent angina pectoris, presumably related to the target vessel;
    • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
    • Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve);
    • A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

  28. Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)

    Time frame: From 1 to 6 months

    TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.

  29. Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)

    Time frame: From 6 to 12 months

    TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.

  30. Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)

    Time frame: From 1 to 12 months

    TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.

  31. Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)

    Time frame: From 1 to 6 months

    TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.

  32. Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)

    Time frame: From 6 to 12 months

    TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.

  33. Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)

    Time frame: From 1 to 12 months

    TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.

  34. Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5

    Time frame: From 1 to 6 months

    Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:

    • Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to < 5 g/dL; Any transfusion with overt bleeding
    • Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents
    • Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision
    • Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period
    • Type 5: Fatal bleeding
    • Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious
    • Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation

  35. Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5

    Time frame: From 6 to 12 months

    Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:

    • Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to < 5 g/dL; Any transfusion with overt bleeding
    • Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents
    • Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision
    • Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period
    • Type 5: Fatal bleeding
    • Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious
    • Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation

  36. Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5

    Time frame: From 1 to 12 months

    Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:

    • Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to < 5 g/dL; Any transfusion with overt bleeding
    • Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents
    • Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision
    • Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period
    • Type 5: Fatal bleeding
    • Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious
    • Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jan 24, 2019
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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