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Trial record 1 of 1 for:    NCT03118895
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Leaders Free III: BioFreedom™ Clinical Trial

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.
 
ClinicalTrials.gov Identifier: NCT03118895
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : October 31, 2022
Sponsor:
Collaborator:
European Cardiovascular Research Center
Information provided by (Responsible Party):
Biosensors Europe SA

Tracking Information
First Submitted Date  ICMJE April 9, 2017
First Posted Date  ICMJE April 18, 2017
Last Update Posted Date October 31, 2022
Actual Study Start Date  ICMJE November 8, 2017
Actual Primary Completion Date February 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
  • MACE: composite of cardiac death, myocardial infarction and definite/probable stent thrombosis (safety) [ Time Frame: at 1 year ]
    Incidence
  • clinically driven target lesion revascularization (efficacy) [ Time Frame: at 1 year ]
    incidence
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2017)
  • All-cause mortality [ Time Frame: At 1 and 4 months, and 1 and 2 years ]
    incidence
  • Clinically Driven Target Lesion Revascularization [ Time Frame: At 1 and 4 months, and 2 years ]
    Incidence
  • Clinically Driven Target Vessel Revascularization [ Time Frame: At 1 and 4 months, and 2 years ]
    Incidence
Original Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
  • All-cause mortality [ Time Frame: At 1 and 4 months, and 1 and 2 years ]
    incidence
  • Clinically Driven Target Lesion Revascularization [ Time Frame: At 1 and 4 months, and 2 years ]
    incidence
  • Clinically Driven Target Vessel Revascularization [ Time Frame: At 1 and 4 months, and 2 years ]
    incidence
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Leaders Free III: BioFreedom™ Clinical Trial
Official Title  ICMJE A Study Evaluating the Safety and Efficacy of the BioFreedom™ Biolimus A9™ Coated Cobalt Chromium Coronary Stent System in Patients at High Risk of Bleeding
Brief Summary A study evaluating the safety and efficacy of the BioFreedom™ Biolimus A9™ coated Cobalt Chromium coronary stent system in patients at high risk of bleeding
Detailed Description Prospective, multi-center, open-label single-arm study designed to enroll 370 HBR patients (for at least 340 evaluable) at up to 20 centers in up to 2 European countries. 370 patients will receive a BioFreedomTM CoCr stent. All patients will be followed up for 2 years.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
370 high bleeding risk items
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiac Death
  • Myocardial Infarction
  • Stent Thrombosis
  • Bleeding
  • Mortality
Intervention  ICMJE Device: BioFreedom™ BA9™ drug-coated stent
Drug-coated stent for coronary arteries
Study Arms  ICMJE Experimental: Treatment Arm
Patients with coronary artery disease at high risk of bleeding receiving the BioFreedom™ BA9™ drug-coated stent
Intervention: Device: BioFreedom™ BA9™ drug-coated stent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 23, 2019)
404
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2017)
370
Actual Study Completion Date  ICMJE October 7, 2022
Actual Primary Completion Date February 5, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients at high bleeding risk (HBR) with an indication for percutaneous coronary intervention who can tolerate no more than one month of 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.

Reasons of unsuitability for > 1 month dual antiplatelet treatment must include one or MORE of the following:

  1. Adjunctive oral anticoagulation treatment planned to continue after PCI
  2. Age ≥ 75 years old
  3. Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to inclusion into the trial)
  4. Any prior intracerebral bleed
  5. Any stroke in the last 12 months
  6. Hospital admission for bleeding during the prior 12 months
  7. Non skin cancer diagnosed or treated ≤ 3 years
  8. Planned daily NSAID (other than aspirin) or steroids for ≥ 30 days after PCI
  9. Planned surgery that would require interruption of DAPT (within next 12 months)
  10. Renal failure defined as: Creatinine clearance <40 ml/min
  11. Thrombocytopenia (PLT <100,000/mm3)
  12. Severe chronic liver disease defined as: patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
  13. Expected non-compliance to prolonged DAPT for other medical reasons

Exclusion Criteria:

  1. Pregnant and breastfeeding women
  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 requires the use of non-study stents, or alternative therapeutic options not followed by stent implantation (angioplasty only, atherectomy only).
  5. Active bleeding at the time of inclusion
  6. If patient requires a stent <2.5mm
  7. If patient requires a stent >3.5mm
  8. Cardiogenic shock
  9. Compliance with long-term single anti-platelet therapy unlikely
  10. Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any another P2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9TM or a sensitivity to contrast media, which cannot be adequately pre-medicated
  11. PCI during the previous 12 months for a lesion other than the target lesion
  12. Participation in another clinical trial (12 months after index procedure)
  13. Patients with a life expectancy of < 1 year
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 75 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Switzerland
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT03118895
Other Study ID Numbers  ICMJE 17EU01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Biosensors Europe SA
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Biosensors Europe SA
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE European Cardiovascular Research Center
Investigators  ICMJE
Principal Investigator: Franz Eberli, Prof. Chief of Cardiology - Triemli Hospital Zurich - Switzerland
Principal Investigator: Philippe Garot, MD Hôpital Privé Claude Galien ICPS - France
PRS Account Biosensors Europe SA
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP