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

University of Freiburg1 site in 1 country240 target enrollmentOctober 2012

ConditionsCoronary Artery Disease

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: University of Freiburg
Enrollment: 240
Locations: 1
Primary Endpoint: Lumen Late Loss
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

December 2013

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Freiburg

Responsible Party

Principal Investigator

Stéphane Cook, Prof

Principal Investigator

University of Freiburg

Eligibility Criteria

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