A Prospective Study of the Biofreedom Biolimus A9 Drug Coated Stent in Patients at High Risk for Bleeding

Trial ID:
IRB-17-6955
Matthew Price
This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study in high bleeding risk patients.

Inclusion Criteria:

    Any indication for percutaneous coronary intervention with stent placement (PCI-S) in patients deemed at high risk for bleeding and candidates for 1 month dual anti-platelet therapy (DAPT). This includes candidates with stable angina, silent ischemia, acute coronary syndrome (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 the index procedure)
    • 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, with a perceived increased risk for bleeding
    • 8. Planned daily Nonsteroidal anti-inflammatory drugs (NSAID) (other than aspirin) or steroids for >30 days after PCI
    • 9. Planned surgery that would require interruption of DAPT (within next 6 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 planned to require non-study stents, or stand-alone plain old balloon angioplasty (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, zinc, Biolimus A9™ or a sensitivity to contrast media, which cannot be adequately pre-medicated
  • 10. PCI during the previous 12 months for a lesion other than the target lesion of the index procedure
  • 11. Participation in another clinical trial (12 months after index procedure)
  • 12. Patients with a life expectancy of < 12 months
  • 13. Patients under judicial protection, tutorship or curatorship (for France only)
  • Why isn't this trial accepting new patients?

    The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting

    How else can Scripps help me?

    We have a broad range of physician expertise and specialized medical services available. You can find a doctor online, call 1-800-SCRIPPS (1-800-727-4777) for personal help, or see related Scripps services.

    How can I find trials that are accepting new participants?

    For more information, see a list of trials that are recruiting, or call the clinical research office at 858-648-6402 for help.