A Randomized Clinical Evaluation of the BioFreedom™ Stent (Leaders Free)

August 17, 2015 updated by: Biosensors Europe SA

A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent Versus the Gazelle Bare Metal Stent in Patients With High Risk of Bleeding.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2456

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Meyrin, Switzerland, 1217
        • Hôpital de La Tour

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any indication for PCI-S in patients deemed at high risk for bleeding and candidates for 1 month DAPT. This includes candidates with stable angina, silent ischemia, ACS (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent.

Exclusion Criteria:

  1. Pregnancy
  2. Patients expected not to comply with 1 month DAPT
  3. Patients requiring a planned staged PCI procedure more than one week after the index procedure
  4. Procedure planned to require non-study stents, or stand alone POBA or stand-alone atherectomy
  5. Active bleeding at the time of inclusion
  6. Reference vessel diameter <2.25 - >4.0mm
  7. Cardiogenic shock
  8. Compliance with long-term single anti-platelet therapy unlikely
  9. A known hypersensitivity or contraindication to aspirin, clopidogrel (or prasugrel, or ticagrelor if applicable), stainless steel, Biolimus A9 or a sensitivity to contrast media, which cannot be adequately pre-medicated.
  10. Participation in another clinical trial (12 months after index procedure).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BioFreedom™ Drug Coated Stent (DCS)
BA9 drug coated stent implantation for improving coronary luminal diameter in patients with de novo lesions in native coronary arteries with a reference vessel diameter between 2.25 mm and 4.0 mm.
Device: Biofreedom™ Drug Coated Stent (DCS)
Biofreedom DCS implantation in high risk bleeding patients followed by 1 month DAPT
Other Names:
  • Drug coated stent
ACTIVE_COMPARATOR: Gazelle™ Bare Metal Coronary Stent (BMS)
GAZELLE™ bare metal stent implantation for improving coronary luminal diameter in patients with de novo lesions in native coronary arteries with a reference vessel diameter between 2.25 and 4.0 mm.
Device: Gazelle™ Bare Metal Coronary Stent (BMS)
Gazelle BMS implantation in high risk bleeding patients followed by 1 month DAPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Safety Endpoint
Time Frame: one year
Composite of cardiac death, myocardial infarction and definite/probable stent thrombosis at one year
one year
Primary Efficacy Endpoint
Time Frame: one year
The incidence of clinically driven target lesion revascularization
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosensors Europe SA

Collaborators

European Cardiovascular Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ANTICIPATED)

June 1, 2016

Study Registration Dates

First Submitted

June 5, 2012

First Submitted That Met QC Criteria

June 15, 2012

First Posted (ESTIMATE)

June 19, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12EU01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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