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

Biosensors Europe SA66 sites in 2 countries1,203 target enrollmentFebruary 14, 2017

ConditionsAcute Coronary Syndrome High Bleeding Risk

InterventionsBioFreedom™ Drug Coated Coronary Stent System Antiplatelet Drug

DrugsAntiplatelet Drug

Overview

Phase: N/A
Intervention: BioFreedom™ Drug Coated Coronary Stent System
Conditions: Acute Coronary Syndrome
Sponsor: Biosensors Europe SA
Enrollment: 1203
Locations: 66
Primary Endpoint: The incidence of clinically driven target lesion revascularization at twelve months
Status: Active, Not Recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

February 14, 2017

End Date

March 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biosensors Europe SA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Any indication for percutaneous coronary intervention with stent placement (PCI-S) in patients deemed at high risk for bleeding and candidates for 1 month dual anti-platelet therapy (DAPT). This includes candidates with stable angina, silent ischemia, acute coronary syndrome (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent.
•Reasons of unsuitability for \> 1 month dual antiplatelet treatment must include one or more of the following:
•Adjunctive oral anticoagulation treatment planned to continue after PCI
•Age ≥ 75 years old
•Baseline Hgb \<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to the index procedure)
•Any prior intracerebral bleed
•Any stroke in the last 12 months
•Hospital admission for bleeding during the prior 12 months
•Non skin cancer diagnosed or treated \< 3 years, with a perceived increased risk for bleeding
•Planned daily Nonsteroidal anti-inflammatory drugs (NSAID) (other than aspirin) or steroids for \>30 days after PCI

Exclusion Criteria

•Pregnant and breastfeeding women
•Patients expected not to comply with 1 month DAPT
•Patients requiring a planned staged PCI procedure more than one week after the index procedure
•Procedure planned to require non-study stents, or stand-alone plain old balloon angioplasty (POBA) or stand-alone atherectomy
•Active bleeding at the time of inclusion
•Reference vessel diameter \<2.25 - \>4.0mm
•Cardiogenic shock
•Compliance with long-term single anti-platelet therapy unlikely
•A known hypersensitivity or contraindication to aspirin, clopidogrel (or prasugrel, or ticagrelor if applicable), stainless steel, zinc, Biolimus A9™ or a sensitivity to contrast media, which cannot be adequately pre-medicated
•PCI during the previous 12 months for a lesion other than the target lesion of the index procedure

Arms & Interventions

BioFreedom™ Drug Coated Stent

Intervention: BioFreedom™ Drug Coated Coronary Stent System

BioFreedom™ Drug Coated Stent

Intervention: Antiplatelet Drug

Outcomes

Primary Outcomes

The incidence of clinically driven target lesion revascularization at twelve months

Time Frame: 12 months

The composite of cardiac death and myocardial infarction at twelve months

Time Frame: 12 months

Secondary Outcomes

Clinically driven target lesion revascularization at time points other than primary endpoint(followed for all target lesion revascularizations, up to 3 years)
Urgent target lesion revascularization(1, 2, and 6 months and 1, 2, and 3 years)
The composite of cardiac death and myocardial infarction(1, 2, and 6 months and 2 and 3 years)
The incidence of clinically driven target lesion revascularization(1, 2, and 6 months and 2 and 3 years)
Clinically driven target vessel revascularization(1, 2, and 6 months and 1, 2, and 3 years)
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)
The composite of cardiac death, myocardial infarction and stent thrombosis(1, 2, and 6 months and 1, 2, and 3 years)
Bleeding per Bleeding Academic Research Consortium (BARC) Criteria(1, 2, and 6 months and 1, 2, and 3 years)
Cardiac Death(1, 2, and 6 months and 1, 2, and 3 years)
Myocardial Infarction(1, 2, and 6 months and 1, 2, and 3 years)
Stent Thrombosis per Academic Research Consortium (ARC) Definition(1, 2, and 6 months and 1, 2, and 3 years)
All cause mortality(1, 2, and 6 months and 1, 2, and 3 years)