A Randomized Clinical Evaluation of the BioFreedom™ Stent
This trial is active, not recruiting.
|Conditions||stable angina, ischemic heart disease silent, st elevation (stemi) and non-st elevation (nstemi) myocardial infarction, in-stent coronary artery restenosis, bleeding|
|Treatments||biofreedom™ drug coated stent (dcs), gazelle™ bare metal coronary stent (bms)|
|Sponsor||Biosensors Europe SA|
|Collaborator||European Cardiovascular Research Center|
|Start date||December 2012|
|End date||May 2015|
|Trial size||2456 participants|
|Trial identifier||NCT01623180, 12EU01|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Composite Safety Endpoint
time frame: one year
Primary Efficacy Endpoint
time frame: one year
Male or female participants at least 18 years old.
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: 1. Pregnancy 2. Patients expected not to comply with 1 month DAPT 3. Patients requiring a planned staged PCI procedure more than one week after the index procedure 4. Procedure planned to require non-study stents, or stand alone POBA or stand-alone atherectomy 5. Active bleeding at the time of inclusion 6. Reference vessel diameter <2.25 - >4.0mm 7. Cardiogenic shock 8. Compliance with long-term single anti-platelet therapy unlikely 9. 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. 10. Participation in another clinical trial (12 months after index procedure).
|Official title||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.|
|Principal investigator||Philip Urban, MD|
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