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NCT02843633 Clinical Trial

LEADERS FREE II: BioFreedom™ Pivotal Study

Acute Coronary Syndrome Clinical Trial

Official title:
A Prospective Study of the BioFreedom™ Biolimus A9™ Drug Coated Stent in Patients at High Risk for Bleeding

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02843633
Other study ID # 16US01
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 14, 2017
Est. completion date March 2021

Study information
Verified date February 2021
Source Biosensors Europe SA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients.

Description:

In this study all patients will receive the BioFreedom™ Drug Coated Stent and one month of Dual Anti Platelet Therapy

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Study Design

Related Conditions & MeSH terms

Intervention

Device:
• BioFreedom™ Drug Coated Coronary Stent System
a non-surgical procedure that uses a catheter to place a stent to open up coronary arteries that have been narrowed by atherosclerosis
Drug:
• Antiplatelet Drug
Dual antiplatelet therapy for one month followed by single antiplatelet therapy indefinitely. Aspirin and clopidogrel (or other P2Y12 inhibitor) will be used and dosing is according to standard institutional practice
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Sponsors (1)
Lead Sponsor Collaborator
Biosensors Europe SA

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  France,  Germany,  Italy,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary The composite of cardiac death and myocardial infarction at twelve months 12 months
Primary The incidence of clinically driven target lesion revascularization at twelve months 12 months
Secondary The composite of cardiac death and myocardial infarction 1, 2, and 6 months and 2 and 3 years
Secondary The incidence of clinically driven target lesion revascularization 1, 2, and 6 months and 2 and 3 years
Secondary The composite of cardiac death, myocardial infarction and stent thrombosis 1, 2, and 6 months and 1, 2, and 3 years
Secondary Bleeding per Bleeding Academic Research Consortium (BARC) Criteria 1, 2, and 6 months and 1, 2, and 3 years
Secondary Cardiac Death 1, 2, and 6 months and 1, 2, and 3 years
Secondary Myocardial Infarction 1, 2, and 6 months and 1, 2, and 3 years
Secondary Stent Thrombosis per Academic Research Consortium (ARC) Definition 1, 2, and 6 months and 1, 2, and 3 years
Secondary Urgent target lesion revascularization 1, 2, and 6 months and 1, 2, and 3 years
Secondary Clinically driven target lesion revascularization at time points other than primary endpoint followed for all target lesion revascularizations, up to 3 years
Secondary Clinically driven target vessel revascularization 1, 2, and 6 months and 1, 2, and 3 years
Secondary All cause mortality 1, 2, and 6 months and 1, 2, and 3 years
Secondary Primary endpoints, in patients with at least 1 lesion treated with a trial stent of 3mm or less in nominal diameter 1, 2, and 6 months and 1, 2, and 3 years
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