NCT02131142

BioFreedom US IDE Feasibility Trial

To Collect Additional Safety and Effectiveness Data for the Biosensors BioFreedom™ BA9 Drug Coated Coronary Stent in Patients With Native, de Novo Coronary Artery Disease

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Biosensors Europe SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Ischemic Heart Disease
• Stable Angina
• Unstable Angina
• Silent Ischemia

Interventions

Type	Name	Description
DEVICE	BioFreedom drug coated coronary stent	Placement of a BioFreedom drug coated stent in a narrow coronary artery

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-08-01
• Completion: 2019-07-01
• First posted: 2014-05-06
• Last updated: 2015-04-01

Locations

13 sites across 1 country: United States