A Randomized Clinical Evaluation of the BioFreedom™ Stent

Study Overview
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Brief Summary
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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.

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

Intervention / Treatment
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* Device: Biofreedom™ Drug Coated Stent (DCS)
* Device: Gazelle™ Bare Metal Coronary Stent (BMS)


Participation Criteria
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Eligibility Criteria
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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: Pregnancy 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BioFreedom™ Drug Coated Stent (DCS)<br>BA9 drug coated stent implantation for improving coronary luminal diameter in patients with de novo lesions in native coronary arteries with a reference vessel diameter between 2.25 mm and 4.0 mm. | Device: Biofreedom™ Drug Coated Stent (DCS)<br>* Biofreedom DCS implantation in high risk bleeding patients followed by 1 month DAPT<br>* Other names: Drug coated stent;|
| Active Comparator: Gazelle™ Bare Metal Coronary Stent (BMS)<br>GAZELLE™ bare metal stent implantation for improving coronary luminal diameter in patients with de novo lesions in native coronary arteries with a reference vessel diameter between 2.25 and 4.0 mm. | Device: Gazelle™ Bare Metal Coronary Stent (BMS)<br>* Gazelle BMS implantation in high risk bleeding patients followed by 1 month DAPT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Safety Endpoint | Composite of cardiac death, myocardial infarction and definite/probable stent thrombosis at one year | one year | 
| Primary Efficacy Endpoint | The incidence of clinically driven target lesion revascularization | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DES, coronary stent, bare metal stent, high bleeding, MI, angina