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

NCT07016698 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-12-17

No results posted yet for this study

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)

Interventions

DEVICE

Rotarex(TM) Rotational Excisional Atherectomy System

Subjects treated with Rotarex(TM) Rotational Excisional Atherectomy System

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Prakash Krishnan, MD, FACC · The Icahn School of Medicine, The Mount Sinai Health System

  • Todd L Berland, MD, FACS · NYU Langone Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-29
Primary Completion
2029-03-31
Completion
2029-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07016698 on ClinicalTrials.gov