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Assessment of the Utility of the Pantheris Small Vessel (SV) System

NCT04793581 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-07-30

No results posted yet for this study

Summary

A single-arm study to assess the utility of the Pantheris SV catheter in addressing peripheral artery disease in arteries located below the knee. Data will be collected on the percent stenosis pre- and post-atherectomy and then symptoms and adverse events noted at 30 days, 6 months, and 1 year after the procedure.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Atherectomy

Directional atherectomy of lesions below the knee.

Sponsors & Collaborators

  • Avinger, Inc.

    lead INDUSTRY

Principal Investigators

  • Jaafer Golzar, MD · Avinger, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-29
Primary Completion
2025-02-01
Completion
2025-08-01
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 NCT04793581 on ClinicalTrials.gov