BioFreedom QCA Study in CAD Patients

NCT03307213 | Unknown DMC

• 1 other identifier: 17EU02
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 2

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.

Conditions

Coronary Artery Disease; Cardiac Death; Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Cardiac Death

  1, 9, 12 and 24 months

• Myocardial infarction

  1, 9, 12 and 24 months

• MACE

  1, 9, 12 and 24 months

Study Arms (2)

BioFreedom™CoCr

EXPERIMENTAL

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

Device: BioFreedom™ CoCr Biolimus A9™ stent

BioFreedom™ SS

ACTIVE COMPARATOR

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

Device: BioFreedom™ SS Biolimus A9™ stent

Interventions

BioFreedom™ CoCr Biolimus A9™ stent DEVICE

Stent implantation

BioFreedom™CoCr

BioFreedom™ SS Biolimus A9™ stent DEVICE

Stent implantation

BioFreedom™ SS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• "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;
• No limitation on the number of treated lesions, and vessels, and lesion length

You may not qualify if:

• 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;

Sponsors & Collaborators

• Biosensors Europe SA: lead

Study Sites (2)

Rigshospitalet, University of Copenhagen

Copenhagen, Denmark

Location

Hospital Clinic de Barcelona

Barcelona, Spain

Location

MeSH Terms

Conditions

Coronary Artery Disease; Death; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Necrosis

Study Officials

• Manel Sabate, Dr.

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: October 11, 2017
• Study Start: June 19, 2018
• Primary Completion: September 30, 2019
• Study Completion: March 31, 2021
• Last Updated: December 24, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); ES (1)