Overview
The XTRACT Registry is a prospective, single arm multicenter study on the use of on the Rotarex(TM) Rotational Excisional Atherectomy System.
Description
The study will recruit approximately 600 subjects treated for PAD.
Eligibility
Inclusion Criteria:
- 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.
- Target lesion can be crossed intra-luminally by guidewire.
- At least one patent native outflow artery to the foot, free from significant stenosis(≥50% stenosis as confirmed by angiography) (ChLI Cohort only, not applicable to ALI Cohort).
Exclusion Criteria:
- 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.
- Life expectancy is below 1 year.
- Pregnant, planning to become pregnant during the course of the study or nursing a child.