Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal

Completed · Not applicable

Conditions studied: Peripheral Artery Disease, PAD, Claudication, Peripheral Vascular Disease, PVD

In brief

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).

Key facts

Study ID

NCT01938391

Run by

Abbott Medical Devices

People needed

25

Starts

2013-01-01

Expected to finish

2015-02-01

Last updated by the study team

2023-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• NYU School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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