BioFreedom QCA Study in CAD Patients (BioFreedomQCA)

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

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.

Study Overview

• Status: Unknown
• Conditions: Myocardial Infarction; Coronary Artery Disease; Cardiac Death
• Intervention / Treatment: Device: BioFreedom™ CoCr Biolimus A9™ stent; Device: BioFreedom™ SS Biolimus A9™ stent

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet, University of Copenhagen
• Spain
  • Barcelona, Spain
    • Hospital Clinic de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Biosensors Europe SA
• Investigators: Principal Investigator: Manel Sabate, Dr., Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Anticipated): March 31, 2021

Study Registration Dates

• First Submitted: October 6, 2017
• First Submitted That Met QC Criteria: October 6, 2017
• First Posted (Actual): October 11, 2017

Study Record Updates

• Last Update Posted (Actual): December 24, 2019
• Last Update Submitted That Met QC Criteria: December 23, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease; Death; Physiological Effects of Drugs; Anti-Infective Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus; Umirolimus
• Other Study ID Numbers: 17EU02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No