Leaders Free III: BioFreedom™ Clinical Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cardiac Death, Myocardial Infarction, Stent Thrombosis, Bleeding, Mortality

Intervention / Treatment
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* Device: BioFreedom™ BA9™ drug-coated stent


Participation Criteria
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Eligibility Criteria
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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: Adjunctive oral anticoagulation treatment planned to continue after PCI Age ≥ 75 years old Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to inclusion into the trial) Any prior intracerebral bleed Any stroke in the last 12 months Hospital admission for bleeding during the prior 12 months Non skin cancer diagnosed or treated ≤ 3 years Planned daily NSAID (other than aspirin) or steroids for ≥ 30 days after PCI Planned surgery that would require interruption of DAPT (within next 12 months) Renal failure defined as: Creatinine clearance <40 ml/min Thrombocytopenia (PLT <100,000/mm3) Severe chronic liver disease defined as: patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice Expected non-compliance to prolonged DAPT for other medical reasons Exclusion Criteria: Pregnant and breastfeeding women Patients expected not to comply with 1 month DAPT Patients requiring a planned staged PCI procedure more than one week after the index procedure Procedure requires the use of non-study stents, or alternative therapeutic options not followed by stent implantation (angioplasty only, atherectomy only). Active bleeding at the time of inclusion If patient requires a stent <2.5mm If patient requires a stent >3.5mm Cardiogenic shock Compliance with long-term single anti-platelet therapy unlikely 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 PCI during the previous 12 months for a lesion other than the target lesion Participation in another clinical trial (12 months after index procedure) Patients with a life expectancy of < 1 year

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Patients with coronary artery disease at high risk of bleeding receiving the BioFreedom™ BA9™ drug-coated stent | Device: BioFreedom™ BA9™ drug-coated stent<br>* Drug-coated stent for coronary arteries<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE: composite of cardiac death, myocardial infarction and definite/probable stent thrombosis (safety) | Incidence | at 1 year | 
| clinically driven target lesion revascularization (efficacy) | incidence | at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | incidence | At 1 and 4 months, and 1 and 2 years | 
| Clinically Driven Target Lesion Revascularization | Incidence | At 1 and 4 months, and 2 years | 
| Clinically Driven Target Vessel Revascularization | Incidence | At 1 and 4 months, and 2 years |