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

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Device: PCI with Xience everolimus-eluting metallic stent; Device: PCI with Absorb everolimus-eluting bioresorbable vascular scaffold

• Registration Number: NCT02796157
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-07
• Study First Submitted QC: 2016-06-07
• Study First Posted: 2016-06-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-17
• Last Update Posted: 2018-05-18
• Primary Completion: 2019-05
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 950

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xience arm	PCI with Xience everolimus-eluting metallic stent	PCI with Xience everolimus-eluting metallic stent
absorb arm	PCI with Absorb everolimus-eluting bioresorbable vascular scaffold	PCI with Absorb everolimus-eluting bioresorbable vascular scaffold

Primary Outcome Measures

Name	Time	Method
Incidence of composite of major adverse cardiovascular events	1 year after PCI	Cardiac death, nonfatal myocardial infarction (MI), stent thrombosis and target-lesion revascularization (TLR)

Trial Locations

Locations (1)

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of