NCT01172119

BioFreedom FIM Clinical Trial.

A Prospective, Single Blinded, Randomized Study to Evaluate the Safety and Effictiveness of a Low and Standard Dose Biolimus A9TM Drug-Eluteing Coronary Stent Delivery System Compared With a TaxusTM LiberteTM Control Arm for Treatment of Stenotic Lesions in Native Coronary Arteries.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Biosensors Europe SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multi center, randomized, single blinded study designed to demonstrate the safety and effectiveness of the Biosensors BioFreedom Drug-Eluting Coronary Stent Delivery System at multiple time points compared to the Taxus Liberte DES in the treatment of single de novo native coronary artery lesions ranging in diameter from ≥2.5 mm to ≤3.0 mm and ≤ 14 mm in length.

Conditions

• Treatment Of Stenotic Lesions In Native Coronary Arteries.

Interventions

Type	Name	Description
DEVICE	Biofreedom Drug Eluting Stent	Biofreedom DES with a standard dose of Biolimus A9TM
DEVICE	Biofreedom Drug Eluting Stent	Biofreedom DES with a low dose of Biolimus A9TM
DEVICE	Tuxus Liberte Drug Eluting Stent	Standard paclitaxel dose Taxus Liberte DES

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-06-01
• Completion: 2014-07-01
• First posted: 2010-07-29
• Last updated: 2014-09-09

Locations

4 sites across 1 country: Germany