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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
European Cardiovascular Research Center
Information provided by (Responsible Party):
Biosensors Europe SA
ClinicalTrials.gov Identifier:
NCT01623180
First received: June 5, 2012
Last updated: August 17, 2015
Last verified: August 2015
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Biosensors Europe SA:

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

  • Primary Efficacy Endpoint [ Time Frame: one year ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Biosensors Europe SA

Additional 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
Study First Received: June 5, 2012
Last Updated: August 17, 2015
Health Authority: SwissMedic: Institut suisse des produits thérapeutiques • Hallerstrasse 7 • Case postale • CH-3000 Berne 9 Tél. +41 31 322 02 11 • Fax +41 31 322 02 12

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

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

ClinicalTrials.gov processed this record on August 26, 2015