BioFreedom US IDE Feasibility Trial

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to collect additional safety and effectiveness data for on the Biosensors BioFreedom™ BA9 Drug Coated Coronary Stent in patients with native, de novo coronary artery disease.

Clinical Trial Description

This is a multi-center prospective trial of 100 patients at up to 15 centers. The study population will consist of patients preventing with symptomatic ischemic heart disease due to de novo stenotic lesion(s) in native coronary artery(ies) with reference vessel diameter between 2.25 mm and 4.0 mm.

The primary safety endpoint for this clinical trial is the occurrence of major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction, target lesion revascularization and academic research consortium (ARC) definite stent thrombosis within 9 months following the implantation.

The primary effectiveness endpoint for this trial is in-stent late lumen loss at 9 months as compared to historical control ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02131142
Study type	Interventional
Source	Biosensors Europe SA
Contact
Status	Active, not recruiting
Phase	Phase 2/Phase 3
Start date	August 2014
Completion date	July 2019

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