BioFreedom QCA Study in CAD Patients

Biosensors Europe SA200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

Coronary Artery Disease Cardiac Death Myocardial Infarction

Interventions

BioFreedom™ CoCr Biolimus A9™ stentDEVICE

Stent implantation

BioFreedom™ SS Biolimus A9™ stentDEVICE

Stent implantation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Rigshospitalet, University of Copenhagen

Copenhagen, Denmark

Hospital Clinic de Barcelona

Barcelona, Spain

Outcomes

Primary Outcomes

In-stent late lumen loss (LLL) at 9 months

In-stent late lumen loss (LLL) assessed by quantitative coronary angiography (QCA) at 9 months

Time frame: 9 months

Secondary Outcomes

Cardiac Death

Time frame: 1, 9, 12 and 24 months

Myocardial infarction

Time frame: 1, 9, 12 and 24 months

MACE

MACE defined as cardiac death, myocardial infarction and clinically indicated

Time frame: 1, 9, 12 and 24 months

Data from ClinicalTrials.gov

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