Endovascular Atherectomy Safety and Effectiveness Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the procedural safety and effectiveness of the Phoenix Atherectomy™ System for the treatment of de novo and restenotic atherosclerotic lesions located in the native peripheral arteries. The Phoenix Atherectomy™ System is intended for use in atherectomy of the peripheral vasculature. The intended peripheral vessels include the Superficial Femoral, Popliteal, and Infrapopliteal arteries. The system is not intended for use in the coronary, carotid, iliac or renal vasculature. The results of this study will be used to support a 510(k) submission to the Food and Drug Administration.

Official Title
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A Prospective, Multicenter Clinical Evaluation of the Safety and Effectiveness of the Phoenix Atherectomy™ System in Atherectomy of the Peripheral Vasculature

Conditions
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Peripheral Vascular Disease

Intervention / Treatment
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* Device: Phoenix Atherectomy System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject willing and able to give informed consent Subject willing and able to comply with the study protocol Age ≥18 years old Objective hemodynamic criteria that subject has a resting ankle-brachial index (ABI) ≤ 0.90, or ≤ 0.75 after exercise, OR patients with non-compressible arteries (ABI>1.1) must have a toe-brachial index (TBI) of ≤ 0.80 Clinical description of lesion as characterized by a Rutherford Clinical Class 2 to 5 Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline Subject has target lesion/lesions defined as stenosis ≥ 70% as determined by operator visual assessment, distal to the profunda femoral artery. No more than two lesions may be treated with the Phoenix device and one of the treated lesions must include a lesion with the worst percent diameter stenosis. Total treated lesion length with the Phoenix device ≤ 10 cm Popliteal and above, target reference vessel diameter (proximal and distal to target lesion) is ≥ 2.5 mm and ≤ 4.5 mm At least one patent tibial vessel runoff at baseline. Below popliteal, target reference vessel diameter (proximal and distal to target lesion) is ≥ 2.5 mm and ≤ 3.5 mm Exclusion Criteria: Patient has an active infection in the target limb Clinical/angiographic complication (other than non-flow limiting dissections) attributed to a currently marketed device prior to introduction of Phoenix System Critical limb ischemia with Rutherford Clinical Class 6 Target lesion containing severe calcification that is circumferential and noted in two views Lesion in the contralateral limb requiring intervention during index procedure or within next 30 days In-stent restenosis within the target lesion Flow limiting dissection, Type C or greater Lesion within a native vessel graft or synthetic graft History of an endovascular procedure or open vascular surgery on the index limb within the last 30 days Subject has any planned surgical or interventional procedure within 30 days after the study procedure Significant acute or chronic kidney disease with a creatinine level >2.5 mg/dl, and/or requiring dialysis Unstable coronary artery disease or other uncontrolled comorbidity Myocardial infarction or stroke within 2 months of baseline evaluation Subject is pregnant or breast-feeding Participation in any study of an investigational device, medication, biologic, or other agent within 30 days prior to enrollment that is either a cardiovascular study or could, in the judgment of the investigator, affect the results of this study Subject has significant stenosis or occlusion of inflow tract (upstream disease) not successfully treated before this procedure Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 125,000/microliter, known coagulopathy, or INR > 1.5 Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated History of heparin-induced thrombocytopenia (HIT) Any thrombolytic therapy within two weeks of enrollment Psychiatric disorder which in the judgment of the investigator could interfere with provision of informed consent, completion of tests, therapy, or follow-up Clinical/angiographic evidence of distal embolization

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: Phoenix Atherectomy System<br> | Device: Phoenix Atherectomy System<br>* Evaluate the procedural safety and effectiveness of the Phoenix Atherectomy™ System for the treatment of de novo and restenotic atherosclerotic lesions located in native peripheral arteries as assessed through 30 day follow-up. Further evaluations of device performance ensuring no prostenotic response as assessed through six month follow-up.<br>* Other names: Percutaneous Atherectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Freedom from Major Adverse Events |  | 30 days | 
| Efficacy: Technical Success | The achievement of acute debulking to achieve a post-Phoenix (prior to any adjunctive therapy) residual diameter stenosis of ≤50%. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Major Adverse Events |  | From 1 month to 6 months post procedure | 
| Procedural success | Procedural success rate is defined as the proportion of the target lesions in which the final stenosis is <30% after treatment with atherectomy and any other adjunctive therapy. | Day 1 | 
| Clinical success | Clinical success rate is defined as the proportion of subjects that have procedural successes in all target lesions with achievement of at least one Rutherford Clinical Scale at 30 days and 6 months post procedure, | 30 days to 6 months | 
| Target vessel Revascularization | Incidence of clinically-driven target vessel revascularization or target limb revascularization. | Treatment through 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral artery disease, Atherectomy, Atherosclerosis