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

Abbott

Status

Completed

Conditions

Claudication

PAD

Peripheral Vascular Disease

Peripheral Artery Disease

PVD

Treatments

Device: Stealth 360°® OAS

Study type

Interventional

Funder types

Industry

Identifiers

NCT01938391

TRUTH

Details and patient eligibility

About

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).

Full 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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject's age ≥ 18 years
Subject is an acceptable candidate for percutaneous intervention using the Sponsor's OAS in accordance with its labeled indications and instructions for use
Target lesion(s) located in a superficial femoral artery (SFA), popliteal (POP) or tibioperoneal trunk (TPT)
Tight lesions (>70% stenosis)
Lesions less than 110 mm in length
Artery with the vessel < 6.5 mm in diameter
Subject is willing and able to sign an approved informed consent form
Subject is willing and able to attend follow-up visits

Exclusion criteria

Uncontrolled allergy to nitinol, stainless-steel or other stent materials or to contrast agent
Unable to take appropriate antiplatelet therapy
Subject has no distal run-off
Interventional treatment is intended for in-stent restenosis at the peripheral vascular site
Subject has history of coagulopathy or hypercoagulable disorder, is undergoing hemodialysis or has impaired renal function (Cr > 2.5 mg/dl) at the time of treatment
Female subject who is pregnant or nursing a child
Intended interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than the Sponsor's OAS