NCT01938391

Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Peripheral Artery Disease
• PAD
• Claudication
• Peripheral Vascular Disease
• PVD

Interventions

Type	Name	Description
DEVICE	Stealth 360°® OAS	Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2013-09-10
• Last updated: 2023-07-18
• Results posted: 2017-08-18

Locations

1 site across 1 country: United States