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

NCT03306199 | Completed Results FDA Device

• 1 other identifier: 17-0906
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are recruited from the investigator's general patient population, and they must meet the inclusion/exclusion criteria.

You may qualify if:

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

You may not qualify if:

• Any incomplete data on procedural approach and treatment

Sponsors & Collaborators

• Spectranetics Corporation: lead

Study Sites (1)

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Research Team Leader
• Organization: Cardiovascular Institute of the South

Deanna.Benoit@cardio.com

(985) 873-5613

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 10, 2017
• Study Start: October 3, 2017
• Primary Completion: June 5, 2018
• Study Completion: June 5, 2018
• Last Updated: April 8, 2019
• Results First Posted: April 8, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)