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

University of Freiburg

Status and phase

Completed

Phase 4

Conditions

Coronary Artery Disease

Treatments

Device: Implantation of everolimus-eluting bioresorbable vascular scaffold stent

Device: Implantation of everolimus-eluting stents

Device: Implantation of biolimus-eluting stents

Study type

Interventional

Funder types

Other

Identifiers

NCT01711931

043/12-CER-FR

Details and patient eligibility

About

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.

Enrollment

240 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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