NCT03307213

BioFreedom QCA Study in CAD Patients

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Biosensors Europe SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Artery Disease
• Cardiac Death
• Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	BioFreedom™ CoCr Biolimus A9™ stent	Stent implantation
DEVICE	BioFreedom™ SS Biolimus A9™ stent	Stent implantation

Timeline

• Start date: 2018-06-19
• Primary completion: 2019-09-30
• Completion: 2021-03-31
• First posted: 2017-10-11
• Last updated: 2019-12-24

Locations

2 sites across 2 countries: Denmark, Spain