Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2018-06-19
2021-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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BioFreedom™CoCr
Patients with CAD will receive the BioFreedom™CoCr stent if randomised to this arm.
BioFreedom™ CoCr Biolimus A9™ stent
Stent implantation
BioFreedom™ SS
Patients with CAD will receive the BioFreedom™SS stent if randomised to this arm.
BioFreedom™ SS Biolimus A9™ stent
Stent implantation
Interventions
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BioFreedom™ CoCr Biolimus A9™ stent
Stent implantation
BioFreedom™ SS Biolimus A9™ stent
Stent implantation
Eligibility Criteria
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Inclusion Criteria
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
2. Known intolerance to aspirin, clopidogrel, heparin, stainless steel, cobalt chromium, Biolimus A9™ or contrast material
3. Inability to provide informed consent;
18 Years
ALL
No
Sponsors
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Biosensors Europe SA
INDUSTRY
Responsible Party
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Principal Investigators
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Manel Sabate, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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Rigshospitalet, University of Copenhagen
Copenhagen, , Denmark
Hospital Clinic de Barcelona
Barcelona, , Spain
Countries
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Other Identifiers
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17EU02
Identifier Type: -
Identifier Source: org_study_id