NCT07016698

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Peripheral Arterial Disease(PAD)

Interventions

Type	Name	Description
DEVICE	Rotarex(TM) Rotational Excisional Atherectomy System	Subjects treated with Rotarex(TM) Rotational Excisional Atherectomy System

Timeline

• Start date: 2025-09-29
• Primary completion: 2029-03-31
• Completion: 2029-05-31
• First posted: 2025-06-12
• Last updated: 2025-12-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study