Back to resultsTurboHawk™ Japan Trial in Patients With PAD
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Atherectomy Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
Eligibility Criteria
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
Sites / Locations
- Kasukabe Chuo General Hospital
- Jikei University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TurboHawk
Arm 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
Outcomes
Primary Outcome Measures
Primary Patency Rate
Secondary Outcome Measures
Technical procedural success
Preservation of the number of run-off vessels determined by angiography
Event free survival
Amputation Rate
Improvement in Rutherford Clinical Category
Improvement in Ankle-Brachial Index
Clinically driven target lesion revascularisation
Clinically driven target vessel revascularisation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02169921
Brief Title
TurboHawk™ Japan Trial in Patients With PAD
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Endovascular
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TurboHawk
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
Atherectomy Catheter
Intervention Description
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 Outcome Measure Information:
Title
Primary Patency Rate
Time Frame
180 Days
Secondary Outcome Measure Information:
Title
Technical procedural success
Time Frame
30 Days
Title
Preservation of the number of run-off vessels determined by angiography
Time Frame
intra operative
Title
Event free survival
Time Frame
30 Days , 180 Days and One Year
Title
Amputation Rate
Time Frame
30 Days , 180 Days and One Year
Title
Improvement in Rutherford Clinical Category
Time Frame
30 Days , 180 Days and One Year
Title
Improvement in Ankle-Brachial Index
Time Frame
30 Days , 180 Days and One Year
Title
Clinically driven target lesion revascularisation
Time Frame
30 Days , 180 Days and One Year
Title
Clinically driven target vessel revascularisation
Time Frame
30 Days , 180 Days and One Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takao Ohki, MD
Organizational Affiliation
Jikei University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hiroshi Ando, MD
Organizational Affiliation
Kasukabe Chuo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasukabe Chuo General Hospital
City
Kasukabe
State/Province
Saitama
ZIP/Postal Code
344-0063
Country
Japan
Facility Name
Jikei University School of Medicine
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
TurboHawk™ Japan Trial in Patients With PAD
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