TurboHawk™ Japan Trial in Patients With PAD

April 12, 2019 updated by: Medtronic Endovascular

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Saitama
      • Kasukabe, Saitama, Japan, 344-0063
        • Kasukabe Chuo General Hospital
    • Tokyo
      • Minato-ku, Tokyo, Japan, 105-8471
        • Jikei University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TurboHawk
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary Patency Rate
Time Frame: 180 Days
180 Days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Endovascular

Investigators

  • Principal Investigator: Hiroshi Ando, MD, Kasukabe Chuo General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

June 8, 2014

First Submitted That Met QC Criteria

June 20, 2014

First Posted (Estimate)

June 23, 2014

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 12, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVJ-12-02-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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