TurboHawk™ Japan Trial in Patients With PAD
Not Applicable
Completed
- Conditions
- Peripheral Arterial Disease
- Interventions
- Device: Atherectomy Catheter
- Registration Number
- NCT02169921
- Lead Sponsor
- Medtronic Endovascular
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TurboHawk Atherectomy Catheter 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
- Primary Outcome Measures
Name Time Method Primary Patency Rate 180 Days
- Secondary Outcome Measures
Name Time Method Improvement in Rutherford Clinical Category 30 Days , 180 Days and One Year Clinically driven target vessel revascularisation 30 Days , 180 Days and One Year Technical procedural success 30 Days Amputation Rate 30 Days , 180 Days and One Year Improvement in Ankle-Brachial Index 30 Days , 180 Days and One Year Preservation of the number of run-off vessels determined by angiography intra operative Event free survival 30 Days , 180 Days and One Year Clinically driven target lesion revascularisation 30 Days , 180 Days and One Year
Trial Locations
- Locations (2)
Kasukabe Chuo General Hospital
🇯🇵Kasukabe, Saitama, Japan
Jikei University School of Medicine
🇯🇵Minato-ku, Tokyo, Japan