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Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System

NCT04282161 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-04-05

No results posted yet for this study

Summary

The primary objective is to demonstrate the safety and effectiveness of the Axys EX rotational atherectomy system in subjects with peripheral arterial disease who have de novo or non-stented restenotic obstructive lesions in the peripheral vasculature of the lower limbs.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Axys EX device

Rotational atherectomy system for endovascular treatment of peripheral arterial disease prior to adjunctive therapy, if needed

Sponsors & Collaborators

  • Medtronic Endovascular

    lead INDUSTRY

Principal Investigators

  • Ravish Sachar, MD FACC · North Carolina Heart and Vascular

  • Brian DeRubertis, MD FACS · University of California, Los Angeles

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2023-08-31
Completion
2024-02-29
FDA Device
Yes

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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 NCT04282161 on ClinicalTrials.gov