An interventional study of Atherectomy Catheter in Peripheral Arterial Disease, sponsored by Medtronic Endovascular. Completed at 2 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Medtronic Endovascular · Not applicable, Interventional, and Treatment
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.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 51 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Medtronic Endovascular is the lead sponsor of 50 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Primary Patency Rate
Time frame: 180 Days
Technical procedural success
Time frame: 30 Days
Preservation of the number of run-off vessels determined by angiography
Time frame: intra operative
Event free survival
Time frame: 30 Days , 180 Days and One Year
Amputation Rate
Time frame: 30 Days , 180 Days and One Year
Improvement in Rutherford Clinical Category
Time frame: 30 Days , 180 Days and One Year
Improvement in Ankle-Brachial Index
Time frame: 30 Days , 180 Days and One Year
Clinically driven target lesion revascularisation
Time frame: 30 Days , 180 Days and One Year
Clinically driven target vessel revascularisation
Time frame: 30 Days , 180 Days and One Year
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medtronic Endovascular