Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents
NCT01711931 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2021-10-22
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.
Conditions
Interventions
- DEVICE
-
Implantation of everolimus-eluting bioresorbable vascular scaffold stent
- DEVICE
-
Implantation of everolimus-eluting stents
- DEVICE
-
Implantation of biolimus-eluting stents
Sponsors & Collaborators
-
University of Freiburg
lead OTHER
Principal Investigators
-
Stéphane Cook, Professor · University of Freiburg
-
Mario Togni, Professor · University of Freiburg
-
Serban Puricel, MD · University of Freiburg
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-10-31
- Primary Completion
- 2013-12-31
- Completion
- 2013-12-31
Countries
- Switzerland
Study Locations
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