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Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal — TRUTH  

Peripheral Artery Disease Clinical Trial

Official title:
Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal (TRUTH Study)

Clinical Trial Summary

IVUS imaging will be utilized to assess performance of the Sponsor's Orbital Atherectomy System (OAS) followed by adjunctive balloon angioplasty (BA) in patients who have symptomatic peripheral artery disease (PAD) occurring in the Superficial Femoral Artery (SFA), Popliteal (POP), and/or Tibioperoneal Trunk (TPT).

Clinical Trial Description

This study is a prospective, single-arm (non-randomized), post-market study which will enroll up to 25 subjects. Intravascular Ultrasound (IVUS) imaging and angiography will be used to assess procedural outcomes in patients who have symptomatic peripheral artery disease who are treated with the Sponsor's OAS and adjunctive balloon angioplasty. An independent IVUS Core Lab will be used to provide adjudicated analyses for IVUS outcomes. In clinic follow-up visits will be performed at 2 weeks, 6 months and at 12 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01938391
Study type Interventional
Source Abbott Medical Devices
Contact
Status Completed
Phase N/A
Start date January 2013
Completion date February 2015
View Details
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