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BioFreedom FIM Clinical Trial.

NCT01172119 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2014-09-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Biosensors Europe SA

    lead INDUSTRY

Principal Investigators

  • Eberhard Grube, Prof Dr med · Department of Cardiology Hospital Alemao O. Cruz, Sao Paulo, Brazil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-06-30
Completion
2014-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01172119 on ClinicalTrials.gov