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A Randomized Clinical Evaluation of the BioFreedom™ Stent

NCT01623180 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2456

Last updated 2015-08-19

No results posted yet for this study

Summary

The purpose of this study is to demonstrate that a BioFreedom™ Drug Coated Stent is non-inferior to a bare metal stent at one year as measured by the composite safety endpoint of cardiovascular death, myocardial infarction and definite/probable stent thrombosis, and that its efficacy is superior to a bare metal stent as measured by clinically driven TLR at one year.

Conditions

  • Stable Angina
  • Ischemic Heart Disease Silent
  • ST Elevation (STEMI) and Non-ST Elevation (NSTEMI) Myocardial Infarction
  • In-stent Coronary Artery Restenosis
  • Bleeding

Interventions

DEVICE

Biofreedom™ Drug Coated Stent (DCS)

Biofreedom DCS implantation in high risk bleeding patients followed by 1 month DAPT

DEVICE

Gazelle™ Bare Metal Coronary Stent (BMS)

Gazelle BMS implantation in high risk bleeding patients followed by 1 month DAPT

Sponsors & Collaborators

  • European Cardiovascular Research Center

    collaborator NETWORK

  • Biosensors Europe SA

    lead INDUSTRY

Principal Investigators

  • Philip Urban, MD · Hôpital de la Tour

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2015-05-31
Completion
2016-06-30

Countries

  • Switzerland

Study Locations

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Entities

Diseases

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 NCT01623180 on ClinicalTrials.gov