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

C. R. Bard

Status: Begins enrollment in 4 months

Conditions: Peripheral Arterial Disease(PAD)

Treatments: Device: Rotarex(TM) Rotational Excisional Atherectomy System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07016698

BDPI-25-001

Details and patient eligibility

About

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

Full description

The study will recruit approximately 600 subjects treated for PAD.

Enrollment: 600 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 1 patient group

Rotarex(TM) Rotational Excisional Atherectomy System

Other group

Description:

Subjects treated with RotarexTM Rotational Excisional Atherectomy System

Treatment:

Device: Rotarex(TM) Rotational Excisional Atherectomy System