Status:
UNKNOWN
BioFreedom QCA Study in CAD Patients
Lead Sponsor:
Biosensors Europe SA
Conditions:
Coronary Artery Disease
Cardiac Death
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- "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
- 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.
Key Trial Info
Start Date :
June 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03307213
Start Date
June 19 2018
End Date
March 31 2021
Last Update
December 24 2019
Active Locations (2)
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1
Rigshospitalet, University of Copenhagen
Copenhagen, Denmark
2
Hospital Clinic de Barcelona
Barcelona, Spain