Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease

Duk-Woo Park, MD1 site in 1 country800 target enrollmentJuly 2016

ConditionsPercutaneous Transluminal Coronary Angioplasty

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Percutaneous Transluminal Coronary Angioplasty
Sponsor: Duk-Woo Park, MD
Enrollment: 800
Locations: 1
Primary Endpoint: Target lesion failure
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether ABSORB bioresorbable vascular scaffold is non-inferior to XIENCE everolimus-eluting cobalt-chromium stent with respect to target-lesion failure (TLF) at 1 year.

Registry

clinicaltrials.gov

Start Date

July 2016

End Date

December 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Duk-Woo Park, MD

Responsible Party

Sponsor Investigator

Principal Investigator

Duk-Woo Park, MD

professor of medicine

Asan Medical Center

Eligibility Criteria

Inclusion Criteria

•Age 18 and more
•Diffuse long native coronary artery stenosis (\>50% by visual estimate) with lesion length of more than 40 mm requiring at least 2 overlapped stents with a reference-vessel diameter of 2.5 to 3.75 mm on visual assessment
•Patients with silent ischemia, stable or unstable angina pectoris, and acute myocardial infarction including NSTEMI or STEMI
•The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site

Exclusion Criteria

•Subject has known hypersensitivity or contraindication to device material and its ingredients (everolimus, poly(L-lactide), poly(DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoro polymers that cannot be adequately premedicated
•Subject has known allergic reaction, hypersensitivity, or contraindication to aspirin; to clopidogrel and prasugrel and ticagrelor; or to heparin and therefore cannot be adequately treated with study medication
•An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs within 12 m after the procedure
•STEMI requiring primary percutaneous coronary intervention
•Cardiogenic shock
•Restenotic lesions
•Left main
•Extreme angulation (≥90°) or excessive tortuosity (≥two 45° angles) proximal to or within the target lesion
•Heavy calcification proximal to or within the target lesion
•Compromised left ventricular dysfunction (LVEF \<30%)

Outcomes

Primary Outcomes

Target lesion failure

Time Frame: 1 year

event rate for composite of cardiac death, target-vessel myocardial infarction \[MI\], or ischemia-driven target-lesion revascularization

Secondary Outcomes

Cardiac death(5 years)
Target-vessel myocardial infarction(5 years)
Ischemia-driven target-lesion revascularization(5 years)
All-cause mortality(5 years)
event rate of any myocardial infarction; Q-wave vs Non-Q wave, periprocedural myocardial infarction vs follow-up myocardial infarction(5 years)
Any revascularization(5 years)
Target-vessel failure(5 years)
Stent thrombosis(5 years)
event rate of device success or procedural success(5 years)
Patient-reported angina status measured by Seattle angina questionnaire(5 years)