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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Cardiac Death Myocardial Infarction Stent Thrombosis Bleeding Mortality Device: BioFreedom™ BA9™ drug-coated stent Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 404 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: 370 high bleeding risk items
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 8, 2017
Actual Primary Completion Date : February 5, 2020
Actual Study Completion Date : October 7, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Arm
Patients with coronary artery disease at high risk of bleeding receiving the BioFreedom™ BA9™ drug-coated stent
 Device: BioFreedom™ BA9™ drug-coated stent
Drug-coated stent for coronary arteries


Outcome Measures
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Primary Outcome Measures :
  1. MACE: composite of cardiac death, myocardial infarction and definite/probable stent thrombosis (safety) [ Time Frame: at 1 year ]
    Incidence

  2. clinically driven target lesion revascularization (efficacy) [ Time Frame: at 1 year ]
    incidence


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: At 1 and 4 months, and 1 and 2 years ]
    incidence

  2. Clinically Driven Target Lesion Revascularization [ Time Frame: At 1 and 4 months, and 2 years ]
    Incidence

  3. Clinically Driven Target Vessel Revascularization [ Time Frame: At 1 and 4 months, and 2 years ]
    Incidence


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT03118895


Locations
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France
at Hôpital Privé Claude Galien ICPS
Quincy sous Sénart, Essonne, France, 91480
Switzerland
Triemli Stadtspital
Zürich, Switzerland
Sponsors and Collaborators
Biosensors Europe SA
European Cardiovascular Research Center
Investigators
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Principal Investigator: Franz Eberli, Prof. Chief of Cardiology - Triemli Hospital Zurich - Switzerland
Principal Investigator: Philippe Garot, MD Hôpital Privé Claude Galien ICPS - France
More Information
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Responsible Party: Biosensors Europe SA
ClinicalTrials.gov Identifier: NCT03118895    
Other Study ID Numbers: 17EU01
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: October 31, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Thrombosis
Infarction
Hemorrhage
Death
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis