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Completed

NCT Number: NCT01925794

COBRA PZF™ Coronary Stent for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term DAPT

This is a prospective, multi-center, non-randomized, single arm clinical trial that will be conducted at up to 40 sites in the United States and Outside United States (OUS). This study will enroll patients with symptomatic ischemic heart disease due to a single de novo lesion contained within a native coronary artery with reference vessel diameter between 2.5 mm and 4.0 mm and lesion length ≤ 24 mm that is amenable to percutaneous coronary intervention (PCI) and stent deployment. All patients will be followed at 30 days, 6 months, 9 months, 1 year and annually for 5 years post index stenting procedure.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Axium, Aix-en-Provence, France

Loading trial locations.

About this study

The main objective of this study is to evaluate the safety and effectiveness of the COBRA PzF™ Coronary Stent System in the treatment of de novo lesions in native coronary arteries. The primary endpoint will be the incidence of target vessel failure (TVF, see definition below) within 270 days of treatment with the COBRA PzFTM Coronary Stent System. This rate will be compared to a performance goal derived using a meta-analysis from published historical data of the standard-of-care therapy, coronary stenting with bare metal stents.

PRIMARY STUDY HYPOTHESIS The CeloNova COBRA PzFTM Study will have a primary endpoint (TVF) rate less than 19.62% and by that will meet the performance goal for bare metal stents, per the results of the historical control group combined with relevant data for EXPRESS™, Driver™, Presillion/Presillion plus™ and NIRFLEX™ stents.

SECONDARY STUDY HYPOTHESIS The powered secondary endpoint for this trial is that the CeloNova COBRA PzFTM Study will have a 9-month in-stent late loss (LL) that meets or is lower than the performance goal of 1.1 mm.

NUMBER OF PATIENTS 296 patients will be enrolled to account for loss to follow-up, which is estimated to be approximately 5% (resulting in 281 evaluable patients), at up to 40 sites in United States and OUS. At least 40% of subjects will be enrolled in the United States.

PRIMARY ENDPOINT Target vessel failure (TVF), defined as cardiac death, target vessel myocardial infarction (MI) [Q wave or non-Q wave, ARC-definition], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 270 days post-procedure.

SECONDARY ENDPOINTS

  • All Death at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days
  • Cardiac Death at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days
  • Major Adverse Cardiac Events (MACE), defined as cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days
  • MI at 30, 180 and 270, 360, 720, 1080, 1440, and 1800 days CeloNova Biosciences, Inc. Confidential CeloNova COBRA PzF™ Study Protocol # COBRA 2012-01 6 07 May 14
  • Clinically driven TLR at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days
  • Stroke (ischemic and hemorrhagic) at 30, 180, 270 and 360 days
  • Clinically driven TVR at 30, 180, 270 and 360 days
  • Composite Endpoint of Cardiac Death and MI at 30, 180, 270, and 360 days
  • TVF at 30, 180, and 360 days
  • Acute Success Rates
  • Device Success: Attainment of < 30% final residual stenosis of the target lesion using only the COBRA PzFTM Coronary Stent System.
  • Lesion Success: Attainment of < 30% final residual stenosis of the target lesion using any percutaneous method.
  • Procedure Success: Attainment of < 30% final residual stenosis of the target lesion and no in-hospital MACE.
  • Bleeding or Vascular Complications at hospital discharge
  • Early Stent Thrombosis (ARC defined) at 30 days
  • Late Stent Thrombosis at 180, 270, and 360 days
  • Angiographic Endpoints (on first 90 evaluable patients) at 270 days (after clinical assessment)
  • In-stent late loss (Secondary Endpoint hypothesis)
  • In-segment percent diameter stenosis (%DS) (within the 5 mm margins proximal and distal to stent)
  • In-stent percent diameter stenosis (%DS)
  • In-segment late loss
  • In-segment binary restenosis (stenosis of > 50% of the reference vessel diameter)
  • In-stent binary restenosis
  • In-stent minimum lumen diameter (MLD)
  • In-segment MLD
  • Longitudinal stent deformation
  • Stent fracture
  • Optical Coherence Tomography Endpoints (on 45 subjects) at 270 days (after clinical assessment)
  • in-stent neointimal thickness (NT)
  • Lumen area
  • Lumen volume
  • Stent area
  • Stent volume
  • Proportion of uncovered and/or malopposed struts
  • Stent fracture

Who can participate

Healthy volunteers accepted: No

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

General Inclusion Criteria:

  • Patient >/= to 18 years old.
  • Eligible for percutaneous coronary intervention (PCI).
  • Patient understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
  • Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.
  • Acceptable candidate for coronary artery bypass graft (CABG) surgery.
  • Stable angina pectoris (Canadian Cardiovascular Society (CCS) 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class 1-3, B-C) or a positive functional ischemia study (e.g., ETT, SPECT, Stress echocardiography or Cardiac CT).
  • Male or non-pregnant female patient (Note: females of child bearing potential must have a negative pregnancy test prior to enrollment in the study).

Angiographic Inclusion Criteria

  • Patient indicated for elective stenting of a single stenotic lesion in a native coronary artery.
  • Reference vessel >/= 2.5 mm and </= 4.0 mm in diameter by visual estimate.
  • Target lesion </= 24 mm in length by visual estimate (the intention should be to cover the whole lesion with one stent of adequate length).
  • Protected left main lesion with >50% stenosis.
  • Target lesion stenosis >/= 70% and < 100% by visual estimate.
  • Target lesion stenosis <70% who meet physiological criteria for revascularization (i.e. positive FFR).

General Exclusion Criteria:

  • Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
  • Previously enrolled in another stent trial within the prior 2 years.
  • ANY planned elective surgery or percutaneous intervention within the subsequent 3 months.
  • A previous coronary interventional procedure of any kind within 30 days prior to the procedure.
  • The patient requires staged procedure of either the target or any non-target vessel within 9 months post-procedure.
  • The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
  • Previous drug eluting stent (DES) deployment anywhere in the target vessel.
  • Any previous stent placement within 15 mm (proximal or distal) of the target lesion.
  • Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
  • Concurrent medical condition with a life expectancy of less than 12 months.
  • Documented left ventricular ejection fraction (LVEF) < 30% within 12 months prior to enrollment.
  • Patients with diagnosis of MI within 72 hours (i.e. CK-MB must be returned to normal prior to enrollment) or suspected acute MI at time of enrollment
  • Previous brachytherapy in the target vessel.
  • History of cerebrovascular accident or transient ischemic attack in the last 6 months.
  • Leukopenia (leukocytes < 3.5 x 10(9) / liter).
  • Neutropenia (Absolute Neutrophil Count < 1000/mm3) </= 3 days prior to enrollment.
  • Thrombocytopenia (platelets < 100,000/mm3) pre-procedure.
  • Active peptic ulcer or active GI bleeding.
  • History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
  • Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, L-605 Cobalt chromium alloy or sensitivity to contrast media, which cannot be adequately pre-medicated.
  • Serum creatinine level > 2.0 mg/dl within 7 days prior to index procedure.
  • Patients unable to tolerate dual anti-platelets therapy (DAPT) for one month post procedure.

Angiographic Exclusion Criteria

  • Unprotected left main coronary artery disease (obstruction greater than 50% in the left main coronary artery that is not protected by at least one non-obstructed bypass graft to the LAD or Circumflex artery or a branch thereof).
  • Target vessel with any lesions with greater than 50% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion based on visual estimate or on-line QCA.
  • Target lesion (or vessel) exhibiting an intraluminal thrombus (occupying > 50% of the true lumen diameter) at any time.
  • Lesion location that is aorto-ostial or within 5 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX).
  • Target lesion with side branches > 2.0mm in diameter.
  • Target vessel is excessively tortuous (two bends > 90˚ to reach the target lesion).
  • Target lesion is severely calcified.
  • TIMI flow 0 or 1
  • Target lesion is in a bypass graft

Treatment and study plan

COBRA PzF

Device

Primary outcomes

  1. Target Vessel Failure (TVF)

    Time frame: 270 days

    TVF defined as cardiac death, target vessel myocardial infarction (MI [Q wave or non-Q wave, ARC definition], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 270 days post-procedure.

Secondary outcomes

  1. All Cause Mortality

    Time frame: 30 days

    Death from any cause

  2. All Cause Mortality

    Time frame: 180 days

    Death from any cause

  3. All Cause Mortality

    Time frame: 270 days

    Death from any cause

  4. All Cause Mortality

    Time frame: 360 days

    Death from any cause

  5. All Cause Mortality

    Time frame: 1800 days

    Death from any cause

  6. Cardiac Mortality

    Time frame: 30 days

    Death due to any of the following:

    Acute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded

  7. Cardiac Mortality

    Time frame: 180 days

    Death due to any of the following:

    Acute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded

  8. Cardiac Mortality

    Time frame: 270 days

    Death due to any of the following:

    Acute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded

  9. Cardiac Mortality

    Time frame: 360 days

    Death due to any of the following:

    Acute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded

  10. Cardiac Mortality

    Time frame: 1800 days

    Death due to any of the following:

    Acute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded

  11. Major Adverse Cardiac Events (MACE)

    Time frame: 30 days

    Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods

  12. Major Adverse Cardiac Events (MACE)

    Time frame: 180 days

    Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods

  13. Major Adverse Cardiac Events (MACE)

    Time frame: 270 days

    Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods

  14. Major Adverse Cardiac Events (MACE)

    Time frame: 360 days

    Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods

  15. Major Adverse Cardiac Events (MACE)

    Time frame: 1800 days

    Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods

  16. Myocardial Infarction (MI-ARC Definition)

    Time frame: 30 days

    Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.

    NQWMI is defined as any elevation of post-procedure CK-MB to >=3 times site normal in the absence of pathological Q waves (historical definition). ARC definition includes Troponin or CK-MB >3 x UNL

  17. Myocardial Infarction (MI-ARC Definition)

    Time frame: 180 days

    Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.

    NQWMI is defined as any elevation of post-procedure CK-MB to >=3 times site normal in the absence of pathological Q waves

  18. Myocardial Infarction (MI-ARC Definition)

    Time frame: 270 days

    Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.

    NQWMI is defined as any elevation of post-procedure CK-MB to >=3 times site normal in the absence of pathological Q waves

  19. Myocardial Infarction (MI-ARC Definition)

    Time frame: 360 days

    Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.

    NQWMI is defined as any elevation of post-procedure CK-MB to >=3 times site normal in the absence of pathological Q waves

  20. Myocardial Infarction (MI-ARC Definition)

    Time frame: 1800 days

    Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.

    NQWMI is defined as any elevation of post-procedure CK-MB to >=3 times site normal in the absence of pathological Q waves

  21. Cardiac Death or MI (ARC Definition)

    Time frame: 30 days

    Composite Endpoint of Cardiac Death or MI (ARC definition)

  22. Cardiac Death or MI (ARC Definition)

    Time frame: 180 days

    Composite Endpoint of Cardiac Death and MI (ARC definition)

  23. Cardiac Death or MI (ARC Definition)

    Time frame: 270 days

    Composite Endpoint of Cardiac Death or MI (ARC definition)

  24. Cardiac Death or MI (ARC Definition)

    Time frame: 360 days

    Composite Endpoint of Cardiac Death or MI (ARC definition)

  25. Clinically Driven TLR

    Time frame: 30 days

    Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.

  26. Clinically Driven TLR

    Time frame: 180 days

    Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.

  27. Clinically Driven TLR

    Time frame: 270 days

    Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.

  28. Clinically Driven TLR (Clinical and Angiographic Cohorts)

    Time frame: 360 days

    Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.

  29. Clinically Driven TLR (Clinical Cohorts)

    Time frame: 360 days

    Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.

  30. Clinically Driven TLR (Clinical and Angiographic Cohorts)

    Time frame: 1800 days

    Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.

  31. Clinically Driven TLR (Clinical Cohorts)

    Time frame: 1800 days

    Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.

  32. Clinically Driven TVR

    Time frame: 30 days

    Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >=70% by QCA without either angina or a positive functional study.

  33. Clinically Driven TVR

    Time frame: 180 days

    Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >=70% by QCA without either angina or a positive functional study.

  34. Clinically Driven TVR

    Time frame: 270 days

    Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >=70% by QCA without either angina or a positive functional study.

  35. Clinically Driven TVR

    Time frame: 360 days

    Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >=70% by QCA without either angina or a positive functional study.

  36. Target Vessel Failure (TVF)

    Time frame: 30 days

    TVF defined as cardiac death, target vessel myocardial infarction (MI) [Q wave or non-Q wave, ARC definition], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods.

  37. Target Vessel Failure (TVF)

    Time frame: 180 days

    TVF defined as cardiac death, target vessel myocardial infarction (MI) [Q wave or non-Q wave, ARC definition], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods.

  38. Target Vessel Failure (TVF)

    Time frame: 360 days

    TVF defined as cardiac death, target vessel myocardial infarction (MI) [Q wave or non-Q wave, ARC definition], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods.

  39. Stroke (Ischemic and Hemorrhagic)

    Time frame: 30 days

    Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.

  40. Stroke (Ischemic and Hemorrhagic)

    Time frame: 180 days

    Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.

  41. Stroke (Ischemic and Hemorrhagic)

    Time frame: 270 days

    Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.

  42. Device Success

    Time frame: 30 days

    Attainment of <30% final residual stenosis of the target lesion using only the COBRA PzF Coronary Stent System

  43. Stroke (Ischemic and Hemorrhagic)

    Time frame: 360 days

    Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.

  44. Lesion Success

    Time frame: 30 days

    Attainment of <30% final residual stenosis of the target lesion using any percutaneous method

  45. Procedure Success

    Time frame: 30 days

    Attainment of <30% final residual stenosis of the target lesion and no in-hospital MACE

  46. Bleeding or Vascular Complications

    Time frame: 30 days

    Bleeding Complications: Procedure-related hemorrhagic event that requires a transfusion and/or surgical intervention Vascular Complications: May include pseudo aneurysm, arteriovenous fistula (AVF), peripheral ischemia/nerve injury, and vascular event requiring transfusion or surgical repair

  47. Early Stent Thrombosis (ARC Definition)

    Time frame: 30 days

    Early Stent Thrombosis (ARC Definition) 0-30 days post index procedure

  48. Late Stent Thrombosis

    Time frame: 180 days

    Stent Thrombosis after 30 days and on or before 180 days

  49. Late Stent Thrombosis

    Time frame: 270 days

    Stent Thrombosis after 30 days and on or before 270 days

  50. Late Stent Thrombosis

    Time frame: 360 days

    Stent Thrombosis after 30 days and on or before 360 days

  51. Definite and Probable Stent Thrombosis

    Time frame: 1800 days

    Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.

  52. In-Segment Percent Diameter Stenosis

    Time frame: 270 days

    Relative changes that occur in the percent diameter stenosis of the segment and are provided by the following relationship: % diameter stenosis= (1-[MLD/Reference diameter]) x 100

  53. In-Stent and In-Segment MLD and Late Loss

    Time frame: 270 days

    • In-stent and in-Segment minimal lumen diameter obtained immediately after stent implantation and at angiographic assessment at 270 days.
    • In-stent or in-segment late loss was defined as the difference between minimum lumen diameter (in-stent or in-segment) immediately after implantation and that obtained at angiographic follow-up at 270 days.

  54. Angiographic Endpoints

    Time frame: 270 days

    Angiographic subset included 115 of the 296 enrolled. Therefore, the overall number of participants analyzed for this outcome measure is 115.

  55. In-stent Neointimal Thickness (INT)

    Time frame: 270 days

    in-stent neointimal thickness assessed by Optical Coherence Tomography

  56. Percentage of Uncovered and/or Malapposed Struts

    Time frame: 270 days

    This measure assess the average proportion of uncovered and or malapposed struts measured by Optical Coherence Tomography in participants

  57. Lumen and Stent Area Measurements

    Time frame: 270 days

    Optical Coherence Tomography assessment of the lumen and stent area after the clinical follow up at 270 days

  58. Lumen and Stent Volume

    Time frame: 270 days

    Optical Coherence Tomography assessment of the lumen and stent volume after the clinical follow up at 270 days

Sponsors and collaborators

Lead sponsor

CeloNova BioSciences, Inc.

Industry

Registry information

Official study title

COBRA PZF™ Coronary Stent System in Native Coronary Arteries for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term Dual Anti-Platelet Therapy. The PzF Shield Trial

Important dates

Study start
2013
Primary completion
2015
Study completion
2020
First posted
Aug 20, 2013
Registry last updated
Dec 22, 2021

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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