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BioFreedom QCA Study in CAD Patients (BioFreedomQCA)

Primary Purpose

Coronary Artery Disease, Cardiac Death, Myocardial Infarction

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

BioFreedom™ CoCr Biolimus A9™ stent

BioFreedom™ SS Biolimus A9™ stent

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Rigshospitalet, University of Copenhagen
Hospital Clinic de Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BioFreedom™CoCr

BioFreedom™ SS

Arm Description

Patients with CAD will receive the BioFreedom™CoCr stent if randomised to this arm.

Patients with CAD will receive the BioFreedom™SS stent if randomised to this arm.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Cardiac Death

Myocardial infarction

MACE

MACE defined as cardiac death, myocardial infarction and clinically indicated

Full Information

NCT ID

NCT03307213

First Posted

October 6, 2017

Last Updated

December 23, 2019

Sponsor

Biosensors Europe SA

1. Study Identification

Unique Protocol Identification Number

NCT03307213

Brief Title

BioFreedom QCA Study in CAD Patients

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 19, 2018 (Actual)

Primary Completion Date

September 30, 2019 (Actual)

Study Completion Date

March 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biosensors Europe SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Cardiac Death, Myocardial Infarction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Participant

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BioFreedom™CoCr

Arm Type

Experimental

Arm Description

Patients with CAD will receive the BioFreedom™CoCr stent if randomised to this arm.

Arm Title

BioFreedom™ SS

Arm Type

Active Comparator

Arm Description

Patients with CAD will receive the BioFreedom™SS stent if randomised to this arm.

Intervention Type

Device

Intervention Name(s)

BioFreedom™ CoCr Biolimus A9™ stent

Intervention Description

Stent implantation

Intervention Type

Device

Intervention Name(s)

BioFreedom™ SS Biolimus A9™ stent

Intervention Description

Stent implantation

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

9 months

Secondary Outcome Measure Information:

Title

Cardiac Death

Description

Cardiac Death

Time Frame

1, 9, 12 and 24 months

Title

Myocardial infarction

Description

Myocardial infarction

Time Frame

1, 9, 12 and 24 months

Title

MACE

Description

MACE defined as cardiac death, myocardial infarction and clinically indicated

Time Frame

1, 9, 12 and 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manel Sabate, Dr.

Organizational Affiliation

Hospital Clinic of Barcelona

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rigshospitalet, University of Copenhagen

City

Copenhagen

Country

Denmark

Facility Name

Hospital Clinic de Barcelona

City

Barcelona

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

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BioFreedom QCA Study in CAD Patients

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