Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Freiburg
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Lumen Late Loss
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Everolimus-eluting bioresorbable vascular scaffold stents
Intervention: Implantation of everolimus-eluting bioresorbable vascular scaffold stent (Device)
Everolimus-eluting stent
Intervention: Implantation of everolimus-eluting stents (Device)
Biolimus-eluting stent
Intervention: Implantation of biolimus-eluting stents (Device)
Outcomes
Primary Outcomes
Lumen Late Loss
Time Frame: 9 months
as assessed by quantitative coronary angiogram
Secondary Outcomes
- Device-oriented major adverse cardiac events(6 months, 1, 2, 5 years)
- Patient-oriented major adverse cardiac events(6 months, 1, 2, 5 years)
Investigators
Stéphane Cook, Prof
Principal Investigator
University of Freiburg