Real-world use of the Rotarex rotational excisional atherectomy device for peripheral arteries

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

This registry will see if the Rotarex rotational excisional atherectomy device can safely and effectively remove blockages in leg arteries for adults with peripheral arterial disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: C. R. Bard (Industry-sponsored)
• Locations: 2 sites (Lakeland, Florida and 1 other locations)
• Trial ID: NCT07016698 on ClinicalTrials.gov

What this trial studies

XTRACT is a prospective, single-arm, multicenter registry enrolling about 600 adults with infra-inguinal peripheral arterial disease treated with the Rotarex rotational excisional atherectomy system according to the device instructions for use. Participants include patients with chronic limb ischemia (Rutherford 2–5) and selected acute limb ischemia (Rutherford I–IIb) whose lesions can be crossed with a guidewire. The registry collects real-world procedural and outcome data across participating centers to characterize device performance and safety. Results will describe procedural success, complications, and mid-term limb outcomes in a broad clinical population.

Who should consider this trial

Good fit: Adults aged 22 or older with infra-inguinal PAD lesions that can be treated with the Rotarex device per the instructions for use, including chronic limb ischemia (Rutherford 2–5) or selected acute limb ischemia (Rutherford I–IIb) and a guidewire-crossable lesion, are ideal candidates.

Not a fit: Patients with vessels under 3 mm in diameter, lesions that cannot be crossed with a guidewire, inability to comply with follow-up, or other contraindications per the device instructions are unlikely to benefit from enrollment.

Why it matters

Potential benefit: If successful, the device could offer a minimally invasive way to clear artery blockages and improve blood flow to the leg, potentially reducing symptoms and the need for more invasive surgery or amputation.

How similar studies have performed: Previous single-center series and smaller registries of the Rotarex device have reported favorable safety and effectiveness for debulking and thrombectomy, and this registry aims to confirm those findings in a larger real-world population.

Eligibility criteria

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-luminally by guidewire.
6. 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:

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 interferes with this protocol and confounds results.
4. Treatment plan includes use of a thrombectomy and/or atherectomy device other than RotarexTM 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 a child.

Where this trial is running

Lakeland, Florida and 1 other locations

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

Study contacts

• Principal investigator: Prakash Krishnan, MD, FACC — The Icahn School of Medicine, The Mount Sinai Health System
• Study coordinator: Adrija Sharma, PhD

Conditions Peripheral Arterial Disease; Rotarex; PAD