Complete Lesion Assessment With ffR and IVUS TechnologY

This prospective, randomized, multi-center, post-market study of approximately 50 subjects randomized 1:1 to Orbital Atherectomy (OA) performed with Cardiovascular Systems, Inc.'s Orbital Atherectomy System (OAS) followed by adjunctive balloon angioplasty (BA) vs. BA alone for treatment of tibial vessel disease, defined as ≥ 50 % stenosis of the anterior tibial (AT), posterior tibial (PT), tibial peroneal trunk (TPT), or peroneal (PR) arteries by angiography. All subjects will have a corresponding wound being fed by the target vessel which will be assessed during the study. Subjects will be followed to one year.

General Inclusion Criteria:

• Subject's age ≥ 18 years.
• Subject is an acceptable candidate for percutaneous intervention with the Sponsor's OAS and BA in accordance with their labeled indications and instructions for use.
• Subject is willing and able to sign an approved informed consent form (ICF).
• Subject is willing and able to attend follow-up and wound care visits.

General Exclusion Criteria:

• Subject is pregnant or planning to become pregnant within the study period.
• Subject is currently participating in an investigational drug or other device study that can clinically interfere with the endpoints of this trial.
• Subject has a known sensitivity to contrast media and the sensitivity cannot be adequately pre-medicated.
• Uncontrolled allergy to nitinol, stainless steel, or other stent materials.
• Subject has known allergy to atherectomy lubricant components such as soybean oil, egg yolk phospholipids, glycerin or sodium hydroxide.
• Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• Subject has been diagnosed with chronic renal failure or has a creatinine level > 2.5, unless on dialysis, prior to the index treatment.
• Subject has evidence of intracranial or gastrointestinal bleeding within 90 days.
• Subject has a history of trauma, fracture, major surgery (includes major amputation), or biopsy of a parenchymal organ within past 14 days, or patient has not healed from a previous medical intervention occurring more than 14 days.
• Subject has a history of stroke or myocardial infarction (MI) within 90 days prior to enrollment in the study.
• Subject has a planned major surgery (includes major amputation) scheduled within 60 days after treatment of the index limb.
• Subject has a planned interventional treatment to address stenosis of the contralateral limb scheduled within 60 days after the index treatment.
• Subject has a planned interventional treatment to address inflow stenosis of the ipsilateral limb scheduled within 60 days after the index treatment.
• Inflow or bilateral PAD requiring treatment prior to enrollment was not successfully treated, defined as > 50% residual stenosis and/or occurrence of procedural angiographic complications, excluding dissection types A and B.
• Subject has previously had their other limb treated as part of the study.

Angiographic Inclusion Criteria:

• Target lesion(s) located in the anterior tibial (AT), posterior tibial (PT), tibial peroneal trunk (TPT) or peroneal (PR) arteries.
• Target lesion has ≥ 50 % stenosis by angiography.
• Subject has a corresponding wound being fed by the target vessel.

Angiographic Exclusion Criteria:

• Target limb does not have any visual flow to the foot confirmed via distal selective angiography.
• Thrombus is present or suspected in the target treatment vessel.
• Target lesion is within a bypass graft or near a previously placed stent.
• The guide wire cannot be passed across the target lesion.
• Anterograde access of the lesion is not possible.
• Subject has angiographic evidence of significant dissection at or near the treatment site.
• Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
• Subject's wound(s) involve multiple angiosomes.