BioFreedom QCA Study in CAD Patients

Not Applicable

• Conditions: Coronary Artery Disease; Cardiac Death; Myocardial Infarction
• Interventions: Device: BioFreedom™ CoCr Biolimus A9™ stent; Device: BioFreedom™ SS Biolimus A9™ stent

• Registration Number: NCT03307213
• Lead Sponsor: Biosensors Europe SA

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-10-06
• Study First Submitted QC: 2017-10-06
• Study First Posted: 2017-10-11
• Study Start: 2018-06-19
• Primary Completion: 2019-09-30
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-23
• Last Update Posted: 2019-12-24
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BioFreedom™CoCr	BioFreedom™ CoCr Biolimus A9™ stent	Patients with CAD will receive the BioFreedom™CoCr stent if randomised to this arm.
BioFreedom™ SS	BioFreedom™ SS Biolimus A9™ stent	Patients with CAD will receive the BioFreedom™SS stent if randomised to this arm.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Myocardial infarction	1, 9, 12 and 24 months	Myocardial infarction
MACE	1, 9, 12 and 24 months	MACE defined as cardiac death, myocardial infarction and clinically indicated
Cardiac Death	1, 9, 12 and 24 months	Cardiac Death

Trial Locations

Locations (2)

Rigshospitalet, University of Copenhagen; 🇩🇰 Copenhagen, Denmark

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain