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

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02796157
• Other study ID #: 1-2016-0025
• Status: Recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: May 2019

Study information

• Verified date: May 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 950
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• PCI with Absorb everolimus-eluting bioresorbable vascular scaffold
Patients allocated to this arm will undergone PCI with Absorb everolimus-eluting bioresorbable vascular scaffold. It will be allowed to used multiple stents for a long coronary lesion.
• PCI with Xience everolimus-eluting metallic stent
Patients allocated to this arm will undergone PCI with Xience everolimus-eluting metallic stent. It will be allowed to used multiple stents for a long coronary lesion.

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of composite of major adverse cardiovascular events	Cardiac death, nonfatal myocardial infarction (MI), stent thrombosis and target-lesion revascularization (TLR)	1 year after PCI