NCT02169921

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

1.3 years

First QC Date

June 8, 2014

Last Update Submit

April 12, 2019

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

  • Primary Patency Rate

    180 Days

Secondary Outcomes (8)

  • Technical procedural success

    30 Days

  • 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

  • Improvement in Rutherford Clinical Category

    30 Days , 180 Days and One Year

  • +3 more secondary outcomes

Study Arms (1)

TurboHawk

EXPERIMENTAL

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

Interventions

Atherectomy CatheterDEVICE

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.

TurboHawk

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kasukabe Chuo General Hospital

Kasukabe, Saitama, 344-0063, Japan

Location

Jikei University School of Medicine

Minato-ku, Tokyo, 105-8471, Japan

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Takao Ohki, MD

    Jikei University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Hiroshi Ando, MD

    Kasukabe Chuo General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2014

First Posted

June 23, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2015

Study Completion

May 1, 2016

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

JP(2)