Cardiac Death, Coronary Artery Disease, Myocardial Infarction
Conditions
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.
Interventions
DEVICEBioFreedom™ CoCr Biolimus A9™ stent
Stent implantation
DEVICEBioFreedom™ SS Biolimus A9™ stent
Stent implantation
Sponsors
Biosensors Europe SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Patients will be randomised to one of the treatment arms to receive either the BioFreedom™ SS or the BioFreedom™ CoCr stent.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Real world, all comer patients 1. Age ≥18 years; 2. 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; 3. 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); 4. No limitation on the number of treated lesions, and vessels, and lesion length
Exclusion criteria
1. Individual is pregnant, nursing or planning to be pregnant; 2. Known intolerance to aspirin, clopidogrel, heparin, stainless steel, cobalt chromium, Biolimus A9™ or contrast material 3. Inability to provide informed consent; Note: Not all
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-stent late lumen loss (LLL) at 9 months | 9 months | In-stent late lumen loss (LLL) assessed by quantitative coronary angiography (QCA) at 9 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Death | 1, 9, 12 and 24 months | Cardiac Death |
| Myocardial infarction | 1, 9, 12 and 24 months | Myocardial infarction |
| MACE | 1, 9, 12 and 24 months | MACE defined as cardiac death, myocardial infarction and clinically indicated |
Countries
Denmark, Spain
Outcome results
None listed