LEADERS FREE II: BioFreedom™ Pivotal Study

Study Overview
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Brief Summary
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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.

Detailed Description
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In this study all patients will receive the BioFreedom™ Drug Coated Stent and one month of Dual Anti Platelet Therapy

Official Title
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A Prospective Study of the BioFreedom™ Biolimus A9™ Drug Coated Stent in Patients at High Risk for Bleeding

Conditions
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Acute Coronary Syndrome, High Bleeding Risk

Intervention / Treatment
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* Device: BioFreedom™ Drug Coated Coronary Stent System
* Drug: Antiplatelet Drug


Participation Criteria
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Eligibility Criteria
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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: 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 the index procedure) 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, with a perceived increased risk for bleeding Planned daily Nonsteroidal anti-inflammatory drugs (NSAID) (other than aspirin) or steroids for >30 days after PCI Planned surgery that would require interruption of DAPT (within next 6 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 planned to require non-study stents, or stand-alone plain old balloon angioplasty (POBA) or stand-alone atherectomy Active bleeding at the time of inclusion Reference vessel diameter <2.25 - >4.0mm Cardiogenic shock Compliance with long-term single anti-platelet therapy unlikely 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 PCI during the previous 12 months for a lesion other than the target lesion of the index procedure Participation in another clinical trial (12 months after index procedure) Patients with a life expectancy of < 12 months Patients under judicial protection, tutorship or curatorship (for France only)
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: BioFreedom™ Drug Coated Stent<br> | Device: BioFreedom™ Drug Coated Coronary Stent System<br>* a non-surgical procedure that uses a catheter to place a stent to open up coronary arteries that have been narrowed by atherosclerosis<br>* Other names: Coronary Angioplasty;Drug: Antiplatelet Drug<br>* Dual antiplatelet therapy for one month followed by single antiplatelet therapy indefinitely. Aspirin and clopidogrel (or other P2Y12 inhibitor) will be used and dosing is according to standard institutional practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The composite of cardiac death and myocardial infarction at twelve months |  | 12 months | 
| The incidence of clinically driven target lesion revascularization at twelve months |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The composite of cardiac death and myocardial infarction |  | 1, 2, and 6 months and 2 and 3 years | 
| The incidence of clinically driven target lesion revascularization |  | 1, 2, and 6 months and 2 and 3 years | 
| The composite of cardiac death, myocardial infarction and stent thrombosis |  | 1, 2, and 6 months and 1, 2, and 3 years | 
| Bleeding per Bleeding Academic Research Consortium (BARC) Criteria |  | 1, 2, and 6 months and 1, 2, and 3 years | 
| Cardiac Death |  | 1, 2, and 6 months and 1, 2, and 3 years | 
| Myocardial Infarction |  | 1, 2, and 6 months and 1, 2, and 3 years | 
| Stent Thrombosis per Academic Research Consortium (ARC) Definition |  | 1, 2, and 6 months and 1, 2, and 3 years | 
| Urgent target lesion revascularization |  | 1, 2, and 6 months and 1, 2, and 3 years | 
| Clinically driven target lesion revascularization at time points other than primary endpoint |  | followed for all target lesion revascularizations, up to 3 years | 
| Clinically driven target vessel revascularization |  | 1, 2, and 6 months and 1, 2, and 3 years | 
| All cause mortality |  | 1, 2, and 6 months and 1, 2, and 3 years | 
| Primary endpoints, in patients with at least 1 lesion treated with a trial stent of 3mm or less in nominal diameter |  | 1, 2, and 6 months and 1, 2, and 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndrome, Percutaneous Coronary Intervention, Drug Coated Stent, Drug Eluting Stent