NCT Number: NCT01589978
This study is designed to observe clinical outcomes in patients receiving the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in routine clinical practice. Patients will have symptomatic heart disease or documented silent ischemia. This is a prospective, open-label consecutively-enrolling study. Clinical follow-up is through 5 years. Approximately 2,689 patients are to be enrolled in up to 65 centers in the United States.
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Interventional
Phase 4
Huntsville Hospital - The Heart Center, PC, Huntsville, Alabama, United States
The wide-spread use of drug-eluting stents (DES) has evolved as standard of care in de novo lesions. The PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients with symptomatic heart disease or documented silent ischemia due to de novo lesions in native coronary arteries ≥2.25 mm to ≤4.00 mm in diameter in lesions ≤34 mm in length. The proposed study will compile real-world clinical outcomes data for the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in routine clinical practice.
Patients enrolled in this study are expected to follow antiplatelet therapy recommendations per American College of Cardiology (ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions (SCAI) guidelines for percutaneous coronary intervention (PCI). Recommended medications include aspirin, which should be taken for 3 days prior to the procedure or as a peri-procedural loading dose and then continued indefinitely. Additionally, one of the following P2Y12 antagonists may be given in a peri-procedural loading dose and in a maintenance dose per physician discretion: clopidogrel, prasugrel, ticagrelor, or ticlopidine.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent) and a drug product (a formulation of everolimus contained in a polymer coating).
Other names: PROMUS Element stent
Aspirin should be taken daily (81 mg) for 3 days prior to the procedure or as a peri-procedural loading dose of 250-500 mg. A maintenance dose of aspirin of at least 81 mg daily, or as indicated by the treating physician, should be continued indefinitely.
Other names: Acetyl salicylic acid
Patients to take one of the following P2Y12 antagonists; maintenance doses to be continued per ACC/AHA/SCAI guidelines for PCI.
Other names: PLAVIX (clopidogrel), TICLID (ticlopidine), EFFIENT (prasugrel), BRILINTA (ticagrelor)
Time frame: 12 months
Cardiac death or myocardial infarction rate at 12 months post implantation in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if rate meets the performance goal (3.2%)
Time frame: 12 months
ARC definite/probable ST rate in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if the annual ST rate increase after the first year meets the performance goal (1.0%)
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)
Time frame: Index Procedure
Compression/elongation of a stent along its long axis resulting from interaction with an ancillary device (e.g., guide catheter) which catches the stent end or an internal stent strut; can occur with advancement or withdrawal of ancillary device. Under fluoroscopy, longitudinal compression usually results in increased strut density and elongation in decreased strut density ('pseudo-fracture'); both can occur in the same stent.
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Composite of cardiac death, myocardial infarction, and target vessel revascularization
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Composite of cardiac death, myocardial infarction, and target vessel revascularization related to the PROMUS Element stent
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
See individual descriptions of events.
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
See individual descriptions of events.
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) related to the target vessel, or death related to the target vessel.
For the purposes of this protocol, if it cannot be determined with certainty whether MI or death was related to the target vessel it will be considered TVF.
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) related to the target vessel, or death related to the target vessel.
For the purposes of this protocol, if it cannot be determined with certainty whether MI or death was related to the target vessel it will be considered TVF.
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
All death includes cardiac death and non-cardiac death.
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Non-cardiac death is defined as death not due to cardiac causes.
Cardiac death is death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded.
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
See description of individual events.
Time frame: 12 Months
Any revascularization of the target vessel, myocardial infarction related to the target vessel, or death related to the target vessel. See individual components for descriptions. Statistical testing will determine if the rate meets the performance goal (12.6%)
Time frame: Annually through 5 years
Using the Academic Research Consortium (ARC) definition, the (definite/probable) stent thrombosis (ST) rate in the PLATINUM-like* population will be analyzed. Statistical testing will be used to determine if the annual increase after the first year in ST rates observed in PLATINUM-like patients meets the performance goal of 1.0% (expected rate of 0.4% + a delta of 0.6%).
Boston Scientific Corporation
Industry
A U.S. Post-Approval Study of the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System
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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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