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

Study on the Use of an Investigational Device for Limb Ischemia

G
Gianvito Salerno

Primary Investigator

Enrolling By Invitation
22 years or above
All
Phase N/A
1 participants needed
1 Location

Brief description of study

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

THIS STUDY IS ENROLLING BY INVITATION ONLY 

Detailed description of study

Device: Rotarex(TM) Rotational Excisional Atherectomy System

  • Subjects treated with Rotarex(TM) Rotational Excisional Atherectomy System
  • After obtaining consent, all subjects will undergo a clinical evaluation at screening. If subjects meet the criteria, they will be treated with the RotarexTM Rotational Excisional Atherectomy System per the investigational site’s standard of care and adhering to the Instructions for Use (IFU). For the Chronic Limb Ischemia Cohort, an ultrasound will be completed at 6 and 12 months post procedure and in-office follow-up visits will be completed at 30 days, 6 months, and 12 months post procedure. There will also be 2 questionnaires for the subjects to complete; the EQ-5D-5L and WIQ (Walking Impairment Questionnaire). For the Acute Limb Ischemia Cohort, both an ultrasound and in-office visit will be completed at 30 days post procedure.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Peripheral Arterial Disease (PAD)
  • Age: 22 years or above
  • Gender: All

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.

This study investigates the use of a special device for treating limb ischemia, which is a condition where blood flow to the limbs is reduced. The device being studied is the investigational Rotarex Rotational Excisional Atherectomy System. Limb ischemia can cause pain and other problems in the legs because of poor blood flow.

Participants will have clinical evaluations and, if eligible, will be treated with the investigational device. For those with chronic limb ischemia, follow-up includes ultrasounds and office visits at 6 and 12 months, and questionnaires about their health and walking ability. For those with acute limb ischemia, follow-up includes an ultrasound and office visit 30 days after the procedure.

  • Who can participate: Adults 22 years and older with specific artery conditions may participate. Key factors include having treatable lesions in the leg arteries and meeting certain health criteria.
  • Study details: Participants will be treated with an investigational device and complete follow-up visits and health questionnaires. The study includes both chronic and acute limb ischemia patients.
Updated on 02 Mar 2026. Study ID: BALL-BARD-XTRACT, 29794
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only