RecruitingNot ApplicableNCT07016698

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

A Prospective, Multicenter, Single Arm, Real-World Registry Assessing the Clinical Use of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)

Sponsor

C. R. Bard

Enrollment

600 participants

Start Date

Sep 29, 2025

Study Type

INTERVENTIONAL

Conditions

Peripheral Arterial Disease(PAD)

Summary

The XTRACT Registry is a prospective, single arm multicenter study on the use of on the Rotarex(TM) Rotational Excisional Atherectomy System.

Eligibility

Min Age: 22 Years

Inclusion Criteria6

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 Criteria6

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.

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