BioFreedom QCA Study in CAD Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of the Efficacy (QCA) and Safety of the BioFreedom™ Biolimus A9™ CoCr Stent in a Randomised Trial in Patients With CAD

Conditions
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Coronary Artery Disease, Cardiac Death, Myocardial Infarction

Intervention / Treatment
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* Device: BioFreedom™ CoCr Biolimus A9™ stent
* Device: BioFreedom™ SS Biolimus A9™ stent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomised to one of the treatment arms to receive either the BioFreedom™ SS or the BioFreedom™ CoCr stent.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BioFreedom™CoCr<br>Patients with CAD will receive the BioFreedom™CoCr stent if randomised to this arm. | Device: BioFreedom™ CoCr Biolimus A9™ stent<br>* Stent implantation<br>|
| Active Comparator: BioFreedom™ SS<br>Patients with CAD will receive the BioFreedom™SS stent if randomised to this arm. | Device: BioFreedom™ SS Biolimus A9™ stent<br>* Stent implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Death | Cardiac Death | 1, 9, 12 and 24 months | 
| Myocardial infarction | Myocardial infarction | 1, 9, 12 and 24 months | 
| MACE | MACE defined as cardiac death, myocardial infarction and clinically indicated | 1, 9, 12 and 24 months |