Early access
Sign in
Taking people in United StatesNo phase

Rotarex device use in people with peripheral arterial disease

Tracks how the Rotarex device is used in people with peripheral arterial disease.

Key facts

Who runs it
C. R. Bard
Where
Humble and Lakeland, United StatesSee the 2 sites
Trial code
Registry title
Real-World Registry of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)
Status
Recruiting
People taking part
600 people, planned
Started
29 Sept 2025
Expected to end
31 May 2029
Type of study
Interventional
Treatments tested
  • Rotarex(TM) Rotational Excisional Atherectomy System
Record updated
17 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with narrowed or blocked leg arteries below the groin. Their blockage must be treatable with the Rotarex(TM) device, which cuts and removes blockage material.

Age
22 years or older.
Sex
All sexes can join.
Disease stage
Long-term poor blood flow to the leg at Rutherford 2-5, or sudden poor blood flow at Rutherford I to IIb. In the long-term group, at least one open artery to the foot without 50% or more narrowing is needed.

Main reasons for not taking part

  • Blockage in a blood vessel less than 3 mm wide.
  • Planned use of another device to remove clots or blockage besides Rotarex(TM).
  • Life expectancy below 1 year.
  • Pregnant, planning pregnancy during the study, or breastfeeding.
  • Unable or unwilling to come to follow-up visits, or in another trial that interferes with this one.

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Subject is participating in another device or drug clinical trial that interferes with this protocol and confounds results
  • 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
  • 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 in United States

  • Vital Heart and VeinHumble, United StatesContact: Adrija SharmaTaking people
  • Radiology and Imaging SpecialistsLakeland, United StatesContact: Adrija SharmaTaking people

About the trial

What the trial wants to find out

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

The group in the trial

  • Rotarex(TM) Rotational Excisional Atherectomy SystemOther group

    Subjects treated with RotarexTM Rotational Excisional Atherectomy System

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Prospective, Multicenter, Single Arm, Real-World Registry Assessing the Clinical Use of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)
Plain-language title
Rotarex device use in people with peripheral arterial diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
17 December 2025