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NCT03306199 Clinical Trial

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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03306199
Other study ID # 17-0906
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 3, 2017
Est. completion date June 5, 2018

Study information
Verified date April 2019
Source Spectranetics Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date June 5, 2018
Est. primary completion date June 5, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Laser Atherectomy
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).

Locations
Country Name City State
United States Cardiovascular Institute of the South Houma Louisiana

Sponsors (1)
Lead Sponsor Collaborator
Spectranetics Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants Free From Target Lesion Revascularization (TLR) A Target Lesion Revascularization is defined as any percutaneous or surgical intervention to treat a restenosis or reocclusion in the target lesion 1 year
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