Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal

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

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).

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.

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