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NCT Number: NCT07016698

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

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

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Key information

Conditions

Peripheral Arterial Disease(PAD) Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radiology and Imaging Specialists, Lakeland, Florida, United States

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About this study

The study will recruit approximately 600 subjects treated for PAD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Rotarex(TM) Rotational Excisional Atherectomy System

Device

Subjects treated with Rotarex(TM) Rotational Excisional Atherectomy System

Primary outcomes

  1. Procedural Success

    Time frame: Immediate Post Index Procedure

    Procedural Success defined as the rate of successful revascularization of target lesion (residual stenosis/thrombus ≤30%) following index procedure.

  2. Freedom from major complications

    Time frame: 30 days post index procedure

    Freedom from composite of device and/or procedure related perioperative (≤30 day) death, unplanned target limb major amputation (above the ankle), and clinically driven target lesion revascularization (CD-TLR) at 30 days post index procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Adrija Sharma, PhD

CONTACT

[email protected]

19014578360

Talar Saber

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jun 12, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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