A Randomized Clinical Evaluation of the BioFreedom™ Stent

Biosensors Europe SA2,456 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

2,456

Conditions

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

Interventions

Biofreedom™ Drug Coated Stent (DCS)DEVICE

Biofreedom DCS implantation in high risk bleeding patients followed by 1 month DAPT

Gazelle™ Bare Metal Coronary Stent (BMS)DEVICE

Gazelle BMS implantation in high risk bleeding patients followed by 1 month DAPT

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Composite Safety Endpoint

Composite of cardiac death, myocardial infarction and definite/probable stent thrombosis at one year

Time frame: one year

Primary Efficacy Endpoint

The incidence of clinically driven target lesion revascularization