Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Implantation of everolimus-eluting bioresorbable vascular scaffold stent; Device: Implantation of biolimus-eluting stents; Device: Implantation of everolimus-eluting stents

• Registration Number: NCT01711931
• Lead Sponsor: University of Freiburg

Brief Summary

The purpose of this study is to compare the efficacy and safety of everolimus- and biolimus-bluting stents with everolimus-eluting bioresorbable vascular scaffold stents.

The null hypothesis to be rejected is that there is no significant difference with regard to lumen late loss at 9 months and a clinical end point of death, myocardial infarction and TVR at 12 months between everolimus-eluting and biolimus-eluting stents and everolimus-eluting bioresorbable vascular scaffold stents.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-18
• Study First Submitted QC: 2012-10-18
• Study First Posted: 2012-10-22
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-05
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• elective PCI
• ability and willingness to provide written informed consent

Exclusion Criteria

• ST-elevation myocardial infarction in the previous 48 hours
• moderate to severe renal failure (defined as creatinine clearance of 30-60 ml/min and <30ml/min respectively)
• known or presumed hypersensitivity to heparin, antiplatelet drugs and hypersensitivity to contrast dye incontrollable with premedication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Everolimus-eluting bioresorbable vascular scaffold stents	Implantation of everolimus-eluting bioresorbable vascular scaffold stent	-
Biolimus-eluting stent	Implantation of biolimus-eluting stents	-
Everolimus-eluting stent	Implantation of everolimus-eluting stents	-

Primary Outcome Measures

Name	Time	Method
Lumen Late Loss	9 months	as assessed by quantitative coronary angiogram

Secondary Outcome Measures

Name	Time	Method
Device-oriented major adverse cardiac events	6 months, 1, 2, 5 years	The composite of cardiac death, myocardial infarction (not clearly attributable to a nontarget vessel) and target lesion revascularization
Patient-oriented major adverse cardiac events	6 months, 1, 2, 5 years	The composite of all-cause mortality, any myocardial infarction and any revascularization

Trial Locations

Locations (1)

Fribourg Cantonal Hospital; 🇨🇭 Fribourg, Switzerland