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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: adrija.sharma@bd.com
• Phone: 19014578360

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.