Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease (ABSORB-LONG)

Duk-Woo Park, MD

Status and phase

Terminated

Phase 4

Conditions

Percutaneous Transluminal Coronary Angioplasty

Treatments

Device: everolimus-eluting cobalt-chromium (Xience) stent

Device: everolimus-eluting bioresorbable vascular (Absorb) scaffold

Study type

Interventional

Funder types

Other

Identifiers

NCT02831205

AMCCV2016-14

Details and patient eligibility

About

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.

Enrollment

800 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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