Leaders Free Japan

Study Overview
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Brief Summary
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Prospective, multi-center, non-randomized, open-label trial designed to enroll 139 patients in Japan. All patients will receive a DCS and will be followed for 2 years.

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

Official Title
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BF-14J01 Drug Coated Stent (DCS) Clinical Trial

Conditions
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Coronary Disease

Intervention / Treatment
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* Procedure: Percutaneous coronary intervention (PCI)
* Drug: Dual Anti Platelet Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any indication for PCI-S in patients deemed at high risk for bleeding and candidates for 1 month 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 enrollment) 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 30 days 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 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 other P2Y12 inhibitor (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 < 1 year
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 |
| --- | --- |
| Other: Drug Coated Stent<br>All patients in the one arm will be treated by PCI with the Drug Coated Stent. | Procedure: Percutaneous coronary intervention (PCI)<br> <br> Drug: Dual Anti Platelet Therapy<br>* All patients will receive Dual Anti Platelet Therapy for one month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients that experienced either a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis. |  | 1 year | 
| The number of patients that experienced a clinically driven target lesion revascularization |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients that experienced a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis |  | 2 years | 
| The number of patients that experienced a clinically driven target lesion revascularization |  | 2 years | 
| The number of patients that experienced a Bleeding per BARC criteria |  | 30, 60 and 120 days, and 12 and 24 months | 
| The number of patients that experienced a cardiac death |  | 30, 60 and 120 days, and 12 and 24 months | 
| The number of patients that experienced a definite/probable stent thrombosis. |  | 30, 60 and 120 days, and 12 and 24 months | 
| The number of patients that experienced a myocardial infarction |  | 30, 60 and 120 days, and 12 and 24 months |