Recruiting

Rotarex

Sponsor:

C. R. Bard

Code:

NCT07016698

Conditions

Peripheral Arterial Disease(PAD)

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Rotarex(TM) Rotational Excisional Atherectomy System

Study Details

Brief summary:

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

Conditions

Peripheral Arterial Disease(PAD)

Study ID

NCT07016698

Start date

Sep 29, 2025

Status verified date

Dec, 2025

Completion date

May 31, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

600 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Rotarex(TM) Rotational Excisional Atherectomy System

Subjects treated with RotarexTM Rotational Excisional Atherectomy System

Interventions

Rotarex(TM) Rotational Excisional Atherectomy System

Subjects treated with Rotarex(TM) Rotational Excisional Atherectomy System

Primary outcome measure

  • Procedural Success [ Time Frame: Immediate Post Index Procedure ]
  • Freedom from major complications [ Time Frame: 30 days post index procedure ]

Central Contacts and Locations

Central contacts

Locations

Radiology and Imaging Specialists

Recruiting

Lakeland, Florida, United States, 33805

Contacts

Vital Heart and Vein

Recruiting

Humble, Texas, United States, 77338

Contacts

More Information

Sponsor

C. R. Bard

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Keywords

  • Rotarex
  • PAD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by C. R. Bard on 2025-12-17.