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JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions

NCT01722877 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2020-03-03

Study results available
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Summary

Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads to improved overall results compared to balloon angioplasty alone. However, scar tissue development can occur within the stent, a process called restenosis. Treatment of these in-stent restenotic lesions has a high procedural success rate but recurrence of scar tissue is frequently seen. Several methods have been proposed to treat in-stent restenosis in the lower leg arteries but mixed results have been noted. In this study we hypothesize that simultaneous tissue excision and aspiration using the JetStream Navitus device (Medrad) can lead to a high rate of acute procedural success with low intraprocedural complications and an acceptable recurrence rate of restenosis at 6-month follow-up.

Conditions

  • Restenosis
  • Peripheral Vascular Disease

Interventions

DEVICE

JetStream Navitus

Study to use Jetstream device for use of in-stent restenosis in femoral popliteal artery.

Sponsors & Collaborators

  • MEDRAD, Inc.

    collaborator INDUSTRY

  • Midwest Cardiovascular Research Foundation

    lead OTHER

Principal Investigators

  • Nicolas W Shammas, MD, MS · Midwest Cardiovascular Research Foundation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-08-31
Completion
2015-09-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT01722877 on ClinicalTrials.gov