TurboHawk™ Japan Trial in Patients With PAD

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02169921

Enrollment

Registered

2014-06-23

Start date

2014-06-30

Completion date

2016-05-31

Last updated

2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

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.

Interventions

DEVICEAtherectomy Catheter

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Primary Patency Rate	180 Days

Secondary

Measure	Time frame
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
Technical procedural success	30 Days
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
Improvement in Rutherford Clinical Category	30 Days , 180 Days and One Year

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026