EVOLVE II: A Prospective Multicenter Trial to Assess the Safety and Effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) for the Treatment of Atherosclerotic Lesion(s)

Boston Scientific Corporation126 sites in 1 country1,684 target enrollmentNovember 2012

ConditionsCoronary Artery Disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Boston Scientific Corporation
Enrollment: 1684
Locations: 126
Primary Endpoint: Percentage of Participants With Target Lesion Failure (TLF) at 12 Months
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety and effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).

Detailed Description

A concurrent, non-randomized, single-arm, pharmacokinetic (PK) substudy and a consecutive, non-randomized, single-arm, Diabetes substudy will also enroll under the EVOLVE II protocol.

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

December 22, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject must be at least 18 years of age
•Subject (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
•For subjects less than 20 years of age enrolled at a Japanese site, the subject and the subject's legal representative must provide written informed consent before any study-specific tests or procedures are performed
•Subject is eligible for percutaneous coronary intervention (PCI)
•Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
•Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
•Subject is willing to comply with all protocol-required follow-up evaluation
•Angiographic Inclusion Criteria (visual estimate):
•Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm
•Target lesion(s) length must be ≤34 mm (by visual estimate)

Exclusion Criteria

•Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)
•Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
•Subject has received an organ transplant or is on a waiting list for an organ transplant
•Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
•Planned PCI (including staged procedures) or CABG after the index procedure
•Subject previously treated at any time with intravascular brachytherapy
•_ Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g., platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin)
•Subject has one of the following (as assessed prior to the index procedure):
•Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months
•Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)

Outcomes

Primary Outcomes

Percentage of Participants With Target Lesion Failure (TLF) at 12 Months

Time Frame: 12 months

TLF is 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.

Secondary Outcomes

Percentage of Participants With Cardiac Death at 12 Month.(12 months)
Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.(12 months)
Percentage of Participants With Target Vessel Failure (TVF) at 12 Month.(12 months)
Percentage of Participants With Myocardial Infarction at 12 Month.(12 months)
Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.(12 months)
Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month.(12 Month)
Percentage of Patients That Died at 12 Months.(12 months)
Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.(12 months)
Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.(12 months)
Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.(12 months)
Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.(12 months)
Percentage of Participants With Non-Cardiac Death at 12 Month.(12 months)
Percentage of Patients With a Stroke at 12 Month.(12 months)
Periprocedural Technical Success Rate.(Day 1 (periprocedure))
Periprocedural Clinical Procedural Success Rate(Day 1 (periprocedure))
Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month.(12 month)