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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioFreedom™CoCr | Experimental | Patients with CAD will receive the BioFreedom™CoCr stent if randomised to this arm. |
|
| BioFreedom™ SS | Active Comparator | Patients with CAD will receive the BioFreedom™SS stent if randomised to this arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioFreedom™ CoCr Biolimus A9™ stent | Device | Stent implantation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| In-stent late lumen loss (LLL) at 9 months | In-stent late lumen loss (LLL) assessed by quantitative coronary angiography (QCA) at 9 months | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Death | Cardiac Death | 1, 9, 12 and 24 months |
| Myocardial infarction | Myocardial infarction | 1, 9, 12 and 24 months |
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Inclusion Criteria:
"Real world, all comer" patients
Exclusion Criteria:
Note: Not all exclusion criteria are listed.
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| Name | Affiliation | Role |
|---|---|---|
| Manel Sabate, Dr. | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet, University of Copenhagen | Copenhagen | Denmark | ||||
| Hospital Clinic de Barcelona |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003643 | Death |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Patients will be randomised to one of the treatment arms to receive either the BioFreedom™ SS or the BioFreedom™ CoCr stent.
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| BioFreedom™ SS Biolimus A9™ stent |
| Device |
Stent implantation |
|
| MACE | MACE defined as cardiac death, myocardial infarction and clinically indicated | 1, 9, 12 and 24 months |
| Barcelona |
| Spain |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |