We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2015 by Biosensors Europe SA.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01623180
First Posted: June 19, 2012
Last Update Posted: August 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
European Cardiovascular Research Center
Information provided by (Responsible Party):
Biosensors Europe SA
  Purpose
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.

Condition Intervention
Stable Angina Ischemic Heart Disease Silent ST Elevation (STEMI) and Non-ST Elevation (NSTEMI) Myocardial Infarction In-stent Coronary Artery Restenosis Bleeding Device: Biofreedom™ Drug Coated Stent (DCS) Device: Gazelle™ Bare Metal Coronary Stent (BMS)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Further study details as provided by Biosensors Europe SA:

Primary Outcome Measures:
  • Composite Safety Endpoint [ Time Frame: one year ]
    Composite of cardiac death, myocardial infarction and definite/probable stent thrombosis at one year

  • Primary Efficacy Endpoint [ Time Frame: one year ]
    The incidence of clinically driven target lesion revascularization


Estimated Enrollment: 2456
Study Start Date: December 2012
Estimated Study Completion Date: June 2016
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623180


Locations
Switzerland
Hôpital de la Tour
Meyrin, Switzerland, 1217
Sponsors and Collaborators
Biosensors Europe SA
European Cardiovascular Research Center
Investigators
Principal Investigator: Philip Urban, MD Hôpital de la Tour
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biosensors Europe SA
ClinicalTrials.gov Identifier: NCT01623180     History of Changes
Other Study ID Numbers: 12EU01
First Submitted: June 5, 2012
First Posted: June 19, 2012
Last Update Posted: August 19, 2015
Last Verified: August 2015

Keywords provided by Biosensors Europe SA:
DES
coronary stent
bare metal stent
high bleeding
MI
angina

Additional relevant MeSH terms:
Infarction
Heart Diseases
Myocardial Infarction
Hemorrhage
Myocardial Ischemia
Coronary Artery Disease
Angina, Stable
Coronary Restenosis
Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Coronary Stenosis