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.

Biosensors Europe SA1 site in 1 country2,456 target enrollmentDecember 2012

ConditionsStable Angina Ischemic Heart Disease Silent ST Elevation (STEMI) and Non-ST Elevation (NSTEMI) Myocardial Infarction In-stent Coronary Artery Restenosis Bleeding

Overview

Phase: N/A
Intervention: Not specified
Conditions: Stable Angina
Sponsor: Biosensors Europe SA
Enrollment: 2456
Locations: 1
Primary Endpoint: Composite Safety Endpoint
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

December 2012

End Date

June 2016

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biosensors Europe SA

Responsible Party

Sponsor

Eligibility Criteria

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).