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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03118895
Other study ID # 17EU01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 8, 2017
Est. completion date November 18, 2022

Study information

Verified date February 2024
Source Biosensors Europe SA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


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Study Design


Intervention

Device:
BioFreedom™ BA9™ drug-coated stent
Drug-coated stent for coronary arteries

Locations

Country Name City State
France at Hôpital Privé Claude Galien ICPS Quincy sous Sénart Essonne
Switzerland Triemli Stadtspital Zürich

Sponsors (2)

Lead Sponsor Collaborator
Biosensors Europe SA European Cardiovascular Research Center

Countries where clinical trial is conducted

France,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary MACE: composite of cardiac death, myocardial infarction and definite/probable stent thrombosis (safety) Incidence at 1 year
Primary clinically driven target lesion revascularization (efficacy) incidence at 1 year
Secondary All-cause mortality incidence At 1 and 4 months, and 1 and 2 years
Secondary Clinically Driven Target Lesion Revascularization Incidence At 1 and 4 months, and 2 years
Secondary Clinically Driven Target Vessel Revascularization Incidence At 1 and 4 months, and 2 years
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