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

Completed

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT03306199
• Lead Sponsor: Spectranetics Corporation

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-03
• Study First Submitted: 2017-10-05
• Study First Submitted QC: 2017-10-05
• Study First Posted: 2017-10-10
• Primary Completion: 2018-06-05
• Study Completion: 2018-06-05
• Results First Submitted: 2018-11-20
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-04
• Last Update Submitted: 2019-04-04
• Results First Posted: 2019-04-08
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Free From Target Lesion Revascularization (TLR)	1 year	A Target Lesion Revascularization is defined as any percutaneous or surgical intervention to treat a restenosis or reocclusion in the target lesion

Trial Locations

Locations (1)

Cardiovascular Institute of the South; 🇺🇸 Houma, Louisiana, United States