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Evaluation of the FreedomFlow™ Orbital Atherectomy System to Treat Peripheral Artery Disease

NCT03635190 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2022-11-04

Study results available
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Summary

To evaluate the safety and effectiveness of the Cardio Flow FreedomFlow™ Orbital Circumferential Atherectomy System for atherosclerotic plaque removal and vessel compliance modification in de novo native target lesions in the peripheral vasculature of the lower extremities.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Orbital Circumferential Atherectomy

Remove atherosclerotic plaque and modify vessel wall compliance within peripheral arterial vessels. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

Sponsors & Collaborators

  • Libra Medical

    collaborator OTHER

  • Cardio Flow, Inc.

    lead INDUSTRY

Principal Investigators

  • Fadi Saab, MD · Advanced Cardiac & Vascular Amputation Prevention Centers

  • Thomas P Davis, MD · Eastlake Cardiovascular

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-17
Primary Completion
2021-03-24
Completion
2021-10-13
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 NCT03635190 on ClinicalTrials.gov