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

Launched by C. R. BARD · Jun 5, 2025

Keywords

ClinConnect Summary

The XTRACT Registry is a clinical study aimed at understanding how well the Rotarex™ Rotational Excisional Atherectomy System works for treating patients with Peripheral Arterial Disease (PAD). This condition affects blood flow to the legs, causing pain and other complications. The study will gather information from multiple medical centers to see how effective this device is in helping those with blockages in their leg arteries.

To participate, individuals must be at least 22 years old and have specific types of blockages in their leg arteries that can be treated with the Rotarex™ system. They should also have at least one healthy artery leading to the foot. However, individuals who are pregnant, have certain medical conditions, or are involved in other clinical trials may not be eligible. Participants will be asked to sign a consent form and will need to attend follow-up visits to monitor their progress throughout the study.

Gender

ALL

Eligibility criteria

• 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.