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BioFreedom QCA Study in CAD Patients — BioFreedomQCA  

Coronary Artery Disease Clinical Trial

Official title:
Evaluation of the Efficacy (QCA) and Safety of the BioFreedom™ Biolimus A9™ CoCr Stent in a Randomised Trial in Patients With CAD

Clinical Trial 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.

Clinical Trial Description

The BioFreedom™ QCA trial is designed to evaluate the safety and efficacy of the BioFreedom™ CoCr DCS coronary stent system compared to the Biofreedom™ stainless steel DCS coronary stent system, in a randomized controlled trial on an all-comers patient population.

The primary objective is to measure non-inferiority of the BioFreedom™ CoCr stent compared to BioFreedom™ DCS as measured by the difference in angiographically measured late lumen loss at 9 months, and the main secondary endpoint is to assess safety as measured by MACE and ST. Two hundred (200) patients will be randomized 1:1 to either stent, allowing for a direct comparison, and will be followed-up to 2 years to measure for late MACE and ST events. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03307213
Study type Interventional
Source Biosensors Europe SA
Contact
Status Active, not recruiting
Phase N/A
Start date June 19, 2018
Completion date March 31, 2021
View Details
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