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Completed

NCT Number: NCT02169921

TurboHawk™ Japan Trial in Patients With PAD

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasukabe Chuo General Hospital, Kasukabe, Saitama, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atherectomy Catheter

Device

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.

Primary outcomes

  1. Primary Patency Rate

    Time frame: 180 Days

Secondary outcomes

  1. Technical procedural success

    Time frame: 30 Days

  2. Preservation of the number of run-off vessels determined by angiography

    Time frame: intra operative

  3. Event free survival

    Time frame: 30 Days , 180 Days and One Year

  4. Amputation Rate

    Time frame: 30 Days , 180 Days and One Year

  5. Improvement in Rutherford Clinical Category

    Time frame: 30 Days , 180 Days and One Year

  6. Improvement in Ankle-Brachial Index

    Time frame: 30 Days , 180 Days and One Year

  7. Clinically driven target lesion revascularisation

    Time frame: 30 Days , 180 Days and One Year

  8. Clinically driven target vessel revascularisation

    Time frame: 30 Days , 180 Days and One Year

Sponsors and collaborators

Lead sponsor

Medtronic Endovascular

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jun 23, 2014
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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