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Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization

NCT02961894 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2020-11-02

Study results available
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Summary

To evaluate the safety and effectiveness of the Revolution™ Peripheral Atherectomy System in the treatment of infrainguinal lower extremity peripheral arterial occlusive disease.

This Atherectomy system will be used on eligible patients with stenosis of at least 70% diameter reduction to evaluate the change in stenosis after the procedure (effectiveness) and the presence of any major adverse events (safety) for up to 30 days after the procedure.

Conditions

Interventions

DEVICE

Revolution™ Peripheral Atherectomy System

The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.

Sponsors & Collaborators

  • Syntactx

    collaborator NETWORK

  • Rex Medical

    lead INDUSTRY

Principal Investigators

  • Jeffrey G Carr, MD · Cardiovascular Associates of East Texas

  • Kenneth Ouriel, MD · Syntactx

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-07
Primary Completion
2019-02-28
Completion
2019-09-20
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02961894 on ClinicalTrials.gov