C. R. Bard
The XTRACT Registry is a prospective, single arm multicenter study on the use of on the Rotarex(TM) Rotational Excisional Atherectomy System.
The study will recruit approximately 600 subjects treated for PAD.
Inclusion Criteria: 1. 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. 2. Subject is ≥22 years old at the time of signing the informed consent. 3. 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). 4. Rutherford 2-5 for chronic limb ischemia and Rutherford I to IIb for acute limb ischemia. 5. Target lesion can be crossed intra-lum…
Subjects treated with Rotarex(TM) Rotational Excisional Atherectomy System
Arctuva estimate
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