BioFreedomQCA: BioFreedom QCA Study in CAD Patients

Sponsor

Biosensors Europe SA (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03307213

Collaborator

(none)

200

Enrollment

Locations

Arms

33.4

Anticipated Duration (Months)

100

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Cardiac Death Myocardial Infarction	Device: BioFreedom™ CoCr Biolimus A9™ stent Device: BioFreedom™ SS Biolimus A9™ stent	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients will be randomised to one of the treatment arms to receive either the BioFreedom™ SS or the BioFreedom™ CoCr stent.Patients will be randomised to one of the treatment arms to receive either the BioFreedom™ SS or the BioFreedom™ CoCr stent.

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 19, 2018

Actual Primary Completion Date :

Sep 30, 2019

Anticipated Study Completion Date :

Mar 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Cardiac Death [1, 9, 12 and 24 months]
Cardiac Death
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

"Real world, all comer" patients

Age ≥18 years;
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;
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);
No limitation on the number of treated lesions, and vessels, and lesion length

Exclusion Criteria:

Individual is pregnant, nursing or planning to be pregnant;
Known intolerance to aspirin, clopidogrel, heparin, stainless steel, cobalt chromium, Biolimus A9™ or contrast material
Inability to provide informed consent;

Note: Not all exclusion criteria are listed.