TurboPower + DCB Treatment of Femoropopliteal De Novo/ Restenotic and In-Stent Restenosis Lesions

A retrospective study to evaluate Turbo Power laser atherectomy + drug coated balloon (DCB) angioplasty for the treatment of femoropopliteal de novo/restenotic lesions and in-stent restenosis (ISR).

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients treated for femoropopliteal de novo/restenotic lesions or in-stent restenosis using Turbo Power laser atherectomy plus drug coated balloon angioplasty

Exclusion criteria

Any incomplete data on procedural approach and treatment

Treatment and study plan

Laser Atherectomy

Device

The Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents with adjunctive percutaneous transluminal angioplasty (PTA).

Primary outcomes

Number of Participants Free From Target Lesion Revascularization (TLR)

Time frame: 1 year

A Target Lesion Revascularization is defined as any percutaneous or surgical intervention to treat a restenosis or reocclusion in the target lesion

Sponsors and collaborators

Lead sponsor

Spectranetics Corporation

Industry

Registry information

Official study title

Turbo Power Laser Atherectomy Combined With Drug Coated Balloon Angioplasty for the Treatment of Femoropopliteal De Novo/ Restenotic and In-Stent Restenosis Lesions

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Oct 10, 2017
Registry last updated: Apr 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed