A Study Evaluating the Safety and Efficacy of the BioFreedom™ Biolimus A9™ Coated Cobalt Chromium Coronary Stent System in Patients at High Risk of Bleeding

Biosensors Europe SA2 sites in 2 countries404 target enrollmentNovember 8, 2017

ConditionsCardiac Death Myocardial Infarction Stent Thrombosis Bleeding Mortality

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiac Death
Sponsor: Biosensors Europe SA
Enrollment: 404
Locations: 2
Primary Endpoint: MACE: composite of cardiac death, myocardial infarction and definite/probable stent thrombosis (safety)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A study evaluating the safety and efficacy of the BioFreedom™ Biolimus A9™ coated Cobalt Chromium coronary stent system in patients at high risk of bleeding

Detailed Description

Prospective, multi-center, open-label single-arm study designed to enroll 370 HBR patients (for at least 340 evaluable) at up to 20 centers in up to 2 European countries. 370 patients will receive a BioFreedomTM CoCr stent. All patients will be followed up for 2 years.

Registry

clinicaltrials.gov

Start Date

November 8, 2017

End Date

November 18, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biosensors Europe SA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients at high bleeding risk (HBR) with an indication for percutaneous coronary intervention who can tolerate no more than one month of DAPT. This includes candidates with stable angina, silent ischemia, ACS (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 inclusion into the trial)
•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
•Planned daily 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 requires the use of non-study stents, or alternative therapeutic options not followed by stent implantation (angioplasty only, atherectomy only).
•Active bleeding at the time of inclusion
•If patient requires a stent \<2.5mm
•If patient requires a stent \>3.5mm
•Cardiogenic shock
•Compliance with long-term single anti-platelet therapy unlikely
•Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any another P2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9TM or a sensitivity to contrast media, which cannot be adequately pre-medicated

Outcomes

Primary Outcomes

MACE: composite of cardiac death, myocardial infarction and definite/probable stent thrombosis (safety)

Time Frame: at 1 year

Incidence

clinically driven target lesion revascularization (efficacy)

Time Frame: at 1 year

incidence

Secondary Outcomes

All-cause mortality(At 1 and 4 months, and 1 and 2 years)
Clinically Driven Target Vessel Revascularization(At 1 and 4 months, and 2 years)
Clinically Driven Target Lesion Revascularization(At 1 and 4 months, and 2 years)