A Randomized Comparison of Clinical Outcomes Between Everolimus-eluting Bioresorbable Vascular Scaffold Versus Everolimus-eluting Metallic Stent in Long Coronary Lesions

Yonsei University

Status

Unknown

Conditions

Coronary Artery Disease

Treatments

Device: PCI with Xience everolimus-eluting metallic stent

Device: PCI with Absorb everolimus-eluting bioresorbable vascular scaffold

Study type

Interventional

Funder types

Other

Identifiers

NCT02796157

1-2016-0025

Details and patient eligibility

About

PCI of diffuse long coronary lesions still remains challenging because of relatively high risk of in-stent restenosis and stent thrombosis compared to short coronary lesions. The purpose of the study is to compare an incidence of composite of major adverse cardiovascular events (MACEs) at 1 year between Absorb everolimus-eluting BVS and Xience EES after coronary intervention in long lesions.

Enrollment

950 estimated patients

Sex

All

Ages

19 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 19-85 years
Patients with ischemic heart disease requiring PCI
Significant coronary de novo lesion (stenosis >50% by quantitative angiographic analysis) requiring stent ≥28 mm in length based on angiographic estimation
Reference vessel diameter of 2.5 to 3.75 mm by operator assessment

Exclusion criteria

Acute myocardial infarction within 48 hours with unstable hemodynamics requiring pharmacologic or mechanical support
Complex coronary morphology including left main disease and bifurcation lesion requiring two-stent technique
Contraindication or hypersensitivity to anti-platelet agents or contrast media
Treated with any metallic stent or BVS within 3 months at other vessel
Cardiogenic shock
Left ventricular ejection fraction <40%
Pregnant women or women with potential childbearing
Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
Inability to understand or read the informed content