TurboHawk™ Japan Trial in Patients With PAD

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02169921
• Other study ID #: CVJ-12-02-01
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: May 2016

Study information

• Verified date: April 2019
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Japan	Kasukabe Chuo General Hospital	Kasukabe	Saitama
Japan	Jikei University School of Medicine	Minato-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

Country where clinical trial is conducted

Japan, 

Outcome

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