TurboHawk™ Japan Trial in Patients With PAD

Medtronic

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Device: Atherectomy Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT02169921

CVJ-12-02-01

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

TurboHawk

Experimental group

Description:

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

Treatment:

Device: Atherectomy Catheter