The XTRACT Registry is a prospective, single arm multicenter study on the use of on the Rotarex(TM) Rotational Excisional Atherectomy System.
Subject or legally authorized representative provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the IRB for the site.
Subject is ≥22 years old at the time of signing the informed consent.
Subject must have a lesion(s) in their infra-inguinal peripheral arteries that can be treated with the RotarexTM Rotational Excisional Atherectomy System according to Instructions For Use (IFU).
Rutherford 2-5 for chronic limb ischemia and Rutherford I to IIb for acute limb ischemia.
Subject is unable or unwilling to comply with follow-up procedures and visits.
Subject has a target lesion in a vessel with less than 3 mm in diameter.
Subject is participating in another device or drug clinical trial that interferes with this protocol and confounds results.
Treatment plan includes use of a thrombectomy and/or atherectomy device other than RotarexTM Rotational Excisional Atherectomy System.
Single group
Rotarex(TM) Rotational Excisional Atherectomy System
DeviceSubjects treated with Rotarex(TM) Rotational Excisional Atherectomy System
Procedural Success
Procedural Success defined as the rate of successful revascularization of target lesion (residual stenosis/thrombus ≤30%) following index procedure.
Freedom from major complications
Freedom from composite of device and/or procedure related perioperative (≤30 day) death, unplanned target limb major amputation (above the ankle), and clinically driven target lesion revascularization (CD-TLR) at 30 days post index procedure
