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

Recruiting now · Not applicable

Conditions studied: Peripheral Arterial Disease(PAD)

In brief

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

Key facts

Study ID

NCT07016698

Run by

C. R. Bard

People needed

600

Starts

2025-09-29

Expected to finish

2029-05-31

Last updated by the study team

2025-12-17

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Radiology and Imaging Specialists — Lakeland, Florida, United States (enrolling)
• Vital Heart and Vein — Humble, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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