PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of up to Two De Novo Coronary Artery Lesions - Small Vessel Sub-trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 94
- Locations
- 23
- Primary Endpoint
- Target Lesion Failure (TLF)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions. The lesions can be located in vessels that are smaller than average-sized.
Detailed Description
The wide-spread use of drug-eluting stents (DES) has evolved as standard of care in de novo lesions. The proposed study will evaluate the safety and effectiveness of PROMUS Element for the treatment of de novo atherosclerotic lesions in native coronary arteries. The study design is consistent with the draft guidance for industry titled, "Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies" (March 2008). During the trial, thienopyridines must be administered according to the 2007 American College of Cardiology (ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions (SCAI) guidelines, which recommended that clopidogrel (75 mg daily) or ticlopidine (250 mg twice daily) be prescribed after stent implantation for at least 6 months in all patients, and for at least 12 months in patients who are not at high risk of bleeding. For sites in the United States, the use of prasugrel is not allowed as part of the PLATINUM Clinical Trial. For sites in other countries, prasugrel may be prescribed according to its approved dosing in countries in which it is available. For patients taking aspirin daily a loading dose is recommended; for patients who have not been taking aspirin daily, aspirin must be administered as a loading dose. Patients continue to take aspirin indefinitely to reduce the risk of thrombosis. This PLATINUM Small Vessel study is a sub-trial associated with the PLATINUM Workhorse Randomized Controlled Trial, which is registered under NCT00823212.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient must be at least 18 years of age
- •Patient (or legal guardian) understands study requirements and treatment procedures and provides written informed consent before any study-specific tests or procedures are performed
- •For patients less than 20 years of age enrolled at a Japanese site, patient and patient's legal representative must provide written informed consent before any study-specific tests or procedures are performed
- •Patient is eligible for percutaneous coronary intervention (PCI)
- •Patient has documented stable angina pectoris or documented silent ischemia; or unstable angina pectoris
- •Patient is an acceptable candidate for coronary artery bypass grafting (CABG)
- •Patient has a left ventricular ejection fraction (LVEF) \>=30% as measured within 30 days prior to enrollment
- •Patient is willing to comply with all protocol-required follow-up evaluations
- •Angiographic Inclusion Criteria (visual estimate):
- •Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter ≥2.25 mm and \<2.5 mm. Target lesion length must measure ≤28 mm by visual estimate. Target lesion must be located in a major coronary artery or branch with visually estimated stenosis ≥50% and \<100% with Thrombolysis In Myocardial Infarction (TIMI) flow \>1.
Exclusion Criteria
- •Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute myocardial infarction (MI)
- •Patient has had a known diagnosis of recent MI (ie, within 72 hours prior to index procedure) and has elevated enzymes at time of index procedure as follows.
- •Patients are excluded if any of the following criteria are met at time of the index procedure.
- •If creatine kinase-myoglobin band (CK-MB) \>2× upper limit of normal (ULN), the patient is excluded regardless of CK Total.
- •If CK-MB is 1-2× ULN, the patient is excluded if the CK Total is \>2× ULN.
- •If CK Total/CK MB are not used and Troponin is, patients are excluded if the following criterion is met at time of index procedure.
- •Troponin \>1× ULN with at least one of the following.
- •Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia (eg, \>1 mm ST segment elevation or depression in consecutive leads or new left bundle branch block \[LBBB\]);
- •Development of pathological Q waves in the ECG; or
- •Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
Outcomes
Primary Outcomes
Target Lesion Failure (TLF)
Time Frame: 12 Months
Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. The primary analysis set for the non-inferiority testing of the primary endpoint is the per-protocol analysis set. All randomized participants who received their assigned treatment are included in the per-protocol analysis set.
Secondary Outcomes
- All Cause Mortality(30 days)
- Target Lesion Revascularization (TLR)(6 months)
- Cardiac Death Related to the Target Vessel(30 days)
- Target Lesion Revascularization TLR)(30 days)
- Acute Technical Success(During the index procedure (minutes))
- Target Lesion Failure (TLF)(30 Days)
- Target Vessel Failure (TVF)(30 Days)
- Myocardial Infarction (MI) Related to the Target Vessel(30 days)
- Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC)Definition(24 hours)
- Target Vessel Revascularization (TVR)(30 days)
- Clinical Procedural Success(Duration of Hospital Stay (average 1-2 days))
- Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition(>30 days-1 year)