TurboHawk™ Japan Trial in Patients With PAD

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and effectiveness of the TurboHawk for the treatment of peripheral arterial disease (PAD) in the superficial femoral and/or the popliteal arteries with the Japanese population.

Official Title
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Determination of Safety and Effectiveness of the TurboHawk and the SpiderFX for the Treatment of Peripheral Arterial Disease in the Superficial Femoral and/or the Popliteal Arteries in Japan

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Atherectomy Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provides written informed consent Willing to comply with follow-up evaluations at specified times Has a Rutherford Clinical Category Score of 2-4 Disease located within the femoropopliteal artery Has evidence of ≥ 50% stenosis or occlusion in the superficial femoral and/or popliteal, confirmed by angiography Each discrete target lesion's length is ≥4cm and ≤ 15 cm Reference vessel diameter is ≥ 3.5 mm and ≤ 7.0 mm Exclusion Criteria: Previously implanted stent(s) or stent graft(s) in target leg Life expectancy less than 12 months Has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure Has in-stent restenosis of the target lesion Has an aneurysmal target vessel Has perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to enrollment

Ages Eligible for Study
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Minimum Age: 20 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: TurboHawk<br>This study is designed as a single arm study. For angioplasty, the Atherectomy Catheter, TurboHawk is used in this arm. Spider FX, the Distal Embolus Protection Device, can concomitantly be used with TurboHawk | Device: Atherectomy Catheter<br>* Atherectomy Catheter, TurboHawk, is used for Angioplasty. Spider FX can concomitantly be used with TurboHawk. TurboHawkTM LS-C, TurboHawk LX-C, TurboHawk SS-CL and TurboHawk SX-C are participated in this arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency Rate |  | 180 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical procedural success |  | 30 Days | 
| Preservation of the number of run-off vessels determined by angiography |  | intra operative | 
| Event free survival |  | 30 Days , 180 Days and One Year | 
| Amputation Rate |  | 30 Days , 180 Days and One Year | 
| Improvement in Rutherford Clinical Category |  | 30 Days , 180 Days and One Year | 
| Improvement in Ankle-Brachial Index |  | 30 Days , 180 Days and One Year | 
| Clinically driven target lesion revascularisation |  | 30 Days , 180 Days and One Year | 
| Clinically driven target vessel revascularisation |  | 30 Days , 180 Days and One Year |