EVERBIOII: Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Everolimus-eluting bioresorbable vascular scaffold stents
|
Device: Implantation of everolimus-eluting bioresorbable vascular scaffold stent
|
Active Comparator: Everolimus-eluting stent
|
Device: Implantation of everolimus-eluting stents
|
Active Comparator: Biolimus-eluting stent
|
Device: Implantation of biolimus-eluting stents
|
Outcome Measures
Primary Outcome Measures
- Lumen Late Loss [9 months]
as assessed by quantitative coronary angiogram
Secondary Outcome Measures
- 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
Other Outcome Measures
- Stent thrombosis [up to 5 years]
possible, probable and definite stent thrombosis
- Periprocedural Complications (occurring <48 hours after the Intervention) [Periprocedural]
Type 4A MI Dissection Perforation
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Fribourg Cantonal Hospital | Fribourg | Switzerland | 1708 |
Sponsors and Collaborators
- University of Freiburg
Investigators
- Study Chair: Stéphane Cook, Professor, University of Freiburg
- Study Director: Mario Togni, Professor, University of Freiburg
- Principal Investigator: Serban Puricel, MD, University of Freiburg
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 043/12-CER-FR