BioFreedom QCA Study in CAD Patients (BioFreedomQCA)

Biosensors International

Status: Unknown

Conditions: Cardiac Death; Coronary Artery Disease; Myocardial Infarction

Treatments: Device: BioFreedom™ CoCr Biolimus A9™ stent; Device: BioFreedom™ SS Biolimus A9™ stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT03307213

17EU02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 exclusion criteria are listed.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

BioFreedom™CoCr

Experimental group

Description:

Patients with CAD will receive the BioFreedom™CoCr stent if randomised to this arm.

Treatment:

Device: BioFreedom™ CoCr Biolimus A9™ stent

BioFreedom™ SS

Active Comparator group

Description:

Patients with CAD will receive the BioFreedom™SS stent if randomised to this arm.

Treatment:

Device: BioFreedom™ SS Biolimus A9™ stent