Coronary Artery Disease
Conditions
Keywords
Drug-eluting stent, Percutaneous coronary intervention, Stent implantation, Evolution Stent System, Biodegradable polymer coating, Feasibility study
Brief summary
The purpose of the EVOLVE Trial is to assess the safety and performance of the everolimus-eluting Evolution stent for the treatment of a de novo atherosclerotic lesion of up to 28 mm in length in a native coronary artery 2.25 mm to 3.5 mm in diameter. The safety and performance of two different drug release rate formulations of the Evolution Stent will be compared to the commercially available PROMUS (TM) Element (TM) drug-eluting stent.
Interventions
DEVICEPROMUS(TM) Element (TM) Stent System
The PROMUS Element Everolimus-Eluting Coronary Stent System is a device/drug combination product composed of two components: a device (coronary stent system) and a drug product (a formulation of everolimus contained in a polymer coating.
DEVICEEvolution Stent System
The Evolution Everolimus-Eluting Monorail Coronary Stent System is a device/drug combination comprised of two regulated components: a device (coronary stent stent) and a drug product (a formulation of everolimus contained in a biodegradable polymer coating).
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must be at least 18 years of age * Patient (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed * Patient is eligible for percutaneous coronary intervention (PCI) * Patient has symptomatic coronary artery disease or documented silent ischemia * Patient is an acceptable candidate for coronary artery bypass grafting (CABG) * Patient has a left ventricular ejection fraction (LVEF) ≥30% as measured within 60 days prior to enrollment * Patient is willing to comply with all protocol-required follow-up evaluations
Exclusion criteria
* Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI * Patient with unstable angina or recent MI (within 72 hours) must have CK/CK-MB or troponin documented prior to the procedure and are excluded if any of the following criteria are met at the time of the index procedure: 1. If CK MB \>2× upper limit of normal (ULN), the patient is excluded regardless of the CK Total. 2. If CK Total \>2× ULN, either CK-MB or troponin must be drawn and the patient is excluded if either CK-MB or troponin is abnormal. 3. If neither CK Total or CK MB is drawn but troponin is, the patient is excluded if: * Troponin \>1× ULN and the patient has at least one of the following: * Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia (e.g., \>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 Note: Patients with stable angina must have CK/CK-MB or troponin drawn prior to the index procedure. However, the results for these patients do not need to be available prior to the index procedure and there are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite safety endpoint of Target Lesion Failure (TLF) at 30 days post-procedure | 30 days | Composite safety endpoint of Target Lesion Failure (TLF) at 30 days post-procedure: * Cardiac Death related to target vessel * Target Vessel Myocardial Infarction (TV-MI) * Target Lesion Revascularization (TLR) |
| In-stent late loss at 6 month post-procedure | 6 months post-procedure | In-stent late loss at 6 months post-procedure measured by Quantitative Coronary Angiography (QCA) |
Secondary
| Measure | Time frame |
|---|---|
| Target lesion failure (TLF) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years | 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years |
| Target vessel failure (TVF) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years | 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years |
| Cardiac death rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years | 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years |
| Target lesion revascularization (TLR) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years | 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years |
| MI rate (TV and overall)at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years | 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years |
| Stent thrombosis rate (by Academic Research Consortium [ARC] definition)at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years | 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years |
| Non-cardiac death rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years | 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years |
| Target vessel revascularization (TVR) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years | 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years |
Countries
Australia, Belgium, Denmark, France, New Zealand, Poland, Spain, Sweden, United Kingdom
Outcome results
None listed