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

COVID-19 update:

In response to the COVID pandemic, Scripps Health has either temporarily suspended or limited enrollment with appropriate precautions for all clinical trials. For questions, please call Scripps Office for the Protection of Research Subjects at 858-678-6402.

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 (NCT01623180) 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

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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.