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

NCT ID: NCT02831205

Last Updated: 2017-12-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-12-31

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.

Conditions

Percutaneous Transluminal Coronary Angioplasty

Keywords

bioresorbable vascular scaffold; coronary artery disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ABSORB BVS

Group Type: EXPERIMENTAL

everolimus-eluting bioresorbable vascular (Absorb) scaffold

Intervention Type: DEVICE

XIENCE EES

Group Type: ACTIVE_COMPARATOR

everolimus-eluting cobalt-chromium (Xience) stent

Intervention Type: DEVICE

Interventions

everolimus-eluting bioresorbable vascular (Absorb) scaffold

Intervention Type: DEVICE

everolimus-eluting cobalt-chromium (Xience) stent

Intervention Type: DEVICE

Other Intervention Names

ABSORB BVS; XIENCE EES

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%)
• At the time of screening, the subject has a malignancy that is not in remission
• Terminal illness with life expectancy <1 year
• Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
• Patient's pregnant or breast-feeding or child-bearing potential

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioVascular Research Foundation, Korea

OTHER

Sponsor Role: collaborator

Duk-Woo Park, MD

OTHER

Sponsor Role: lead

Responsible Party

Duk-Woo Park, MD

professor of medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

AMCCV2016-14

Identifier Type: -

Identifier Source: org_study_id