Evaluation of the Efficacy (QCA) and Safety of the BioFreedom™ Biolimus A9™ CoCr Stent in a Randomised Trial in Patients With CAD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Biosensors Europe SA
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- In-stent late lumen loss (LLL) at 9 months
- Last Updated
- 6 years ago
Overview
Brief Summary
This study aims to demonstrate that the BioFreedom™ Cobalt Chromium Drug Coated Stent is non-inferior to the market authorized BioFreedom™ Stainless Steel Stent with respective to efficacy and shows a similar safety profile.
Detailed Description
The BioFreedom™ QCA trial is designed to evaluate the safety and efficacy of the BioFreedom™ CoCr DCS coronary stent system compared to the Biofreedom™ stainless steel DCS coronary stent system, in a randomized controlled trial on an all-comers patient population. The primary objective is to measure non-inferiority of the BioFreedom™ CoCr stent compared to BioFreedom™ DCS as measured by the difference in angiographically measured late lumen loss at 9 months, and the main secondary endpoint is to assess safety as measured by MACE and ST. Two hundred (200) patients will be randomized 1:1 to either stent, allowing for a direct comparison, and will be followed-up to 2 years to measure for late MACE and ST events.
Investigators
Eligibility Criteria
Inclusion Criteria
- •"Real world, all comer" patients
- •Age ≥18 years;
- •Symptomatic coronary artery disease including patients with chronic stable angina, unstable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction and ST-elevation myocardial infarction;
- •Presence of one or more coronary artery stenosis \>50% in a native coronary artery or a saphenous bypass graft from 2.50 to 3.5 mm in diameter that can be covered with one or multiple stents (angiographic inclusion);
- •No limitation on the number of treated lesions, and vessels, and lesion length
Exclusion Criteria
- •Individual is pregnant, nursing or planning to be pregnant;
- •Known intolerance to aspirin, clopidogrel, heparin, stainless steel, cobalt chromium, Biolimus A9™ or contrast material
- •Inability to provide informed consent;
- •Note: Not all exclusion criteria are listed.
Outcomes
Primary Outcomes
In-stent late lumen loss (LLL) at 9 months
Time Frame: 9 months
In-stent late lumen loss (LLL) assessed by quantitative coronary angiography (QCA) at 9 months
Secondary Outcomes
- Cardiac Death(1, 9, 12 and 24 months)
- Myocardial infarction(1, 9, 12 and 24 months)
- MACE(1, 9, 12 and 24 months)