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Feasibility Clinical Trial of the Cardio Flow Orbital Atherectomy System to Treat Peripheral Artery Disease (PAD)

NCT03365154 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-05-20

Study results available
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Summary

This trial is a First in Human early feasibility study of a novel atherectomy device to treat peripheral artery disease. The trial is a prospective, single arm design that will enroll 10 patients at 1 - 2 sites. Patients will be followed at 30 days and 6 months to evaluate vessel patency following treatment. Safety will be assessed by monitoring adverse events throughout the study. Safety and Efficacy will be evaluated by comparing study results to established performance criteria,

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment

Occlusive lesions will be treated using atherectomy with or without adjunctive low pressure balloon angioplasty.

DEVICE

Balloon Angioplasty

Low pressure balloon angioplasty may be used following atherectomy

Sponsors & Collaborators

  • Libra Medical

    collaborator OTHER

  • Cardio Flow, Inc.

    lead INDUSTRY

Principal Investigators

  • Phil Zang, MD · Libra Medical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-25
Primary Completion
2018-02-22
Completion
2018-11-06
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 NCT03365154 on ClinicalTrials.gov