NCT01623180UnknownNot Applicable
A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent Versus the Gazelle Bare Metal Stent in Patients With High Risk of Bleeding.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Biosensors Europe SA
- Enrollment
- 2,456
- Locations
- 2
- Primary Endpoint
- Composite Safety Endpoint
Study Overview
Brief Summary
The purpose of this study is to demonstrate that a BioFreedom™ Drug Coated Stent is non-inferior to a bare metal stent at one year as measured by the composite safety endpoint of cardiovascular death, myocardial infarction and definite/probable stent thrombosis, and that its efficacy is superior to a bare metal stent as measured by clinically driven TLR at one year.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Any indication for PCI-S in patients deemed at high risk for bleeding and candidates for 1 month DAPT. This includes candidates with stable angina, silent ischemia, ACS (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent.
Exclusion Criteria
- •Patients expected not to comply with 1 month DAPT
- •Patients requiring a planned staged PCI procedure more than one week after the index procedure
- •Procedure planned to require non-study stents, or stand alone POBA or stand-alone atherectomy
- •Active bleeding at the time of inclusion
- •Reference vessel diameter <2.25 - >4.0mm
- •Cardiogenic shock
- •Compliance with long-term single anti-platelet therapy unlikely
- •A known hypersensitivity or contraindication to aspirin, clopidogrel (or prasugrel, or ticagrelor if applicable), stainless steel, Biolimus A9 or a sensitivity to contrast media, which cannot be adequately pre-medicated.
- •Participation in another clinical trial (12 months after index procedure).
Outcomes
Primary Outcomes
Composite Safety Endpoint
Time Frame: one year
Composite of cardiac death, myocardial infarction and definite/probable stent thrombosis at one year
Primary Efficacy Endpoint
Time Frame: one year
The incidence of clinically driven target lesion revascularization
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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