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Recruiting NCT07016698

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

No phase Interventional Peripheral Arterial Disease(PAD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rotarex(TM) Rotational Excisional Atherectomy System.
Who it may be relevant to
Registry conditions: Peripheral Arterial Disease(PAD). Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

The study will recruit approximately 600 subjects treated for PAD.

Interventions

  • Device Rotarex(TM) Rotational Excisional Atherectomy System
    Subjects treated with Rotarex(TM) Rotational Excisional Atherectomy System

Primary outcome measures

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Radiology and Imaging Specialists — Lakeland
  • Vital Heart and Vein — Humble

Identifiers

NCT: NCT07016698 · BDPI-25-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗