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Pantheris Atherectomy Treatment of In-Stent Restenosis In Lower Extremity Arteries

NCT03192696 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2023-03-28

No results posted yet for this study

Summary

A prospective, non-randomized, international, multi-center study to evaluate the safety and effectiveness of the Pantheris OCT-Imaging System to perform atherectomy in In-Stent Restenotic (ISR) lesions in lower extremity arteries.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Atherectomy Catheter

Treatment of restenotic lesions within stents previously placed within the artery.

Sponsors & Collaborators

  • Avinger, Inc.

    lead INDUSTRY

Principal Investigators

  • Sean Janzer, MD · Einstein Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-19
Primary Completion
2021-06-01
Completion
2021-12-01
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 NCT03192696 on ClinicalTrials.gov