BioFreedom QCA Study in CAD Patients

Coronary Artery Disease Clinical Trial

— BioFreedomQCA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03307213
• Other study ID #: 17EU02
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 19, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: December 2019
• Source: Biosensors Europe SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: March 31, 2021
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Death
• Coronary Artery Disease
• Death
• Infarction
• Myocardial Infarction

Intervention

Device:
• BioFreedom™ CoCr Biolimus A9™ stent
Stent implantation
• BioFreedom™ SS Biolimus A9™ stent
Stent implantation

Locations

Country	Name	City	State
Denmark	Rigshospitalet, University of Copenhagen	Copenhagen
Spain	Hospital Clinic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Biosensors Europe SA

Countries where clinical trial is conducted

Denmark,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cardiac Death	Cardiac Death	1, 9, 12 and 24 months
Secondary	Myocardial infarction	Myocardial infarction	1, 9, 12 and 24 months
Secondary	MACE	MACE defined as cardiac death, myocardial infarction and clinically indicated	1, 9, 12 and 24 months