BioFreedom US IDE Feasibility Trial

Study Overview
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Brief Summary
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The purpose of this study is to collect additional safety and effectiveness data for on the Biosensors BioFreedom™ BA9 Drug Coated Coronary Stent in patients with native, de novo coronary artery disease.

Detailed Description
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This is a multi-center prospective trial of 100 patients at up to 15 centers. The study population will consist of patients preventing with symptomatic ischemic heart disease due to de novo stenotic lesion(s) in native coronary artery(ies) with reference vessel diameter between 2.25 mm and 4.0 mm. The primary safety endpoint for this clinical trial is the occurrence of major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction, target lesion revascularization and academic research consortium (ARC) definite stent thrombosis within 9 months following the implantation. The primary effectiveness endpoint for this trial is in-stent late lumen loss at 9 months as compared to historical control

Official Title
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To Collect Additional Safety and Effectiveness Data for the Biosensors BioFreedom™ BA9 Drug Coated Coronary Stent in Patients With Native, de Novo Coronary Artery Disease

Conditions
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Ischemic Heart Disease, Stable Angina, Unstable Angina, Silent Ischemia

Intervention / Treatment
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* Device: BioFreedom drug coated coronary stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individual is ≥ 18 years of age Individual must have clinical evidence if ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study; Individual must be an acceptable candidate for percutaneous coronary intervention (PCI), stenting, and emergent coronary artery bypass graft (CABG) surgery Individual is competent and willing to provide informed consent to participate in the trial Exclusion Criteria: A known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, or a sensitivity to contrast media that cannot be adequately pre-medicated; History or known allergic reaction or significant sensitivity to drugs similar to BA9; A platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, or a WBC < 3,000 cells/mm3; A creatinine level > 2.5 mg/dL; Evidence of an acute myocardial infarction with 72 hours of the intended stenting (defined as: Q wave or non-Q wave myocardial infarction having a Troponin either I or T pre-procedure elevated above the Institution's upper limit of normal); Previous or planned PCI of any vessel within 30 days pre or post procedure; Patient unable to take clopidogrel for 3 months or patient who have comorbidities that would prohibit the cessation of clopidogrel at 3 months; Planned adjunctive treatment during the intended stenting (eg balloon valvuloplasty, percutaneous endovascular intervention, etc) During the intended or index procedure the target lesion(s) requires treatment with a device other than a plain old balloon prior to stent placement (such as, but not limited to, cutting balloon, directional atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc); History of documented prior stroke within 6 months of the intended procedure; Active peptic ulcer or upper gastrointestinal bleeding documented within the prior 6 months; History of active bleeding diathesis or coagulopathy or will refuse blood transfusion; Individual is pregnant, nursing or planning to be pregnant; Any previous or planned treatment of the target vessel(s) with anti-restenotic therapies including, but not limited to brachytherapy; Concurrent medical condition with a life expectancy of less than 12 months or individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study; Individual is currently enrolled in another investigational drug or device trial. If, however, if investigational trial device or drug becomes commercially available, these trials are not considered investigational; Previous ACS within 9 months of pre or post procedure

Ages Eligible for Study
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Minimum Age: 18 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: BioFreedom<br> | Device: BioFreedom drug coated coronary stent<br>* Placement of a BioFreedom drug coated stent in a narrow coronary artery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the BioFreedom stent | The occurrence of major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction, target lesion revascularization and academic research consortium (ARC) definite stent thrombosis | 9 month | 
| Efficacy of the BioFreedom stent | Stent late lumen loss at 9 months as compared to historical control | 9 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic heart disease, CAD