TurboHawk™ Japan Trial in Patients With PAD | NCT02169921

Studies
TurboHawk™ Japan Trial in Patients With PAD

NCT02169921

Sponsor

Medtronic Endovascular

Status

Completed

Last Update Posted

Apr 16, 2019Actual

Enrollment

51Actual

Phase

Not Applicable

Conditions

Peripheral Arterial Disease

Interventions

Atherectomy Catheter

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Sep 2015Actual

Completion Date

May 2016Actual

First Submitted Date

Jun 8, 2014

First Submission Date that Met QC Criteria

Jun 20, 2014

First Posted Date

Jun 23, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2019

Last Update Posted Date

Apr 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary Patency Rate		180 Days

Secondary Outcomes

Measure	Description	Time Frame
Technical procedural success		30 Days
Preservation of the number of run-off vessels determined by angiography		intra operative
Event free survival

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Takao Ohki, MD	Jikei University School of Medicine	Principal Investigator
Hiroshi Ando, MD	Kasukabe Chuo General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasukabe Chuo General Hospital		Kasukabe	Saitama	344-0063	Japan
Jikei University School of Medicine

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058729	Peripheral Arterial Disease

Ancestor Terms

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided