Real-World Registry of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)

Inclusion Criteria:

1. Subject or legally authorized representative provides written informed consent usingan Informed Consent Form (ICF) that is reviewed and approved by the IRB for thesite.

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 canbe treated with the RotarexTM Rotational Excisional Atherectomy System according toInstructions For Use (IFU).

4. Rutherford 2-5 for chronic limb ischemia and Rutherford I to IIb for acute limbischemia.

5. Target lesion can be crossed intra-luminally by guidewire.

6. At least one patent native outflow artery to the foot, free from significantstenosis(≥50% stenosis as confirmed by angiography) (ChLI Cohort only, notapplicable to ALI Cohort).

Exclusion Criteria:

1. Subject is unable or unwilling to comply with follow-up procedures and visits.

2. Subject has a target lesion in a vessel with less than 3 mm in diameter.

3. Subject is participating in another device or drug clinical trial that interfereswith this protocol and confounds results.

4. Treatment plan includes use of a thrombectomy and/or atherectomy device other thanRotarexTM Rotational Excisional Atherectomy System.

5. Life expectancy is below 1 year.

6. Pregnant, planning to become pregnant during the course of the study or nursing achild.