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FLUENCY® PLUS Endovascular Stent Graft for In-stent Restenosis

NCT01257438 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2017-01-09

Study results available
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Summary

The primary purpose of this study is to demonstrate that the FLUENCY® PLUS Endovascular Stent Graft can effectively and safely treat in-stent restenotic lesions in the venous outflow of the Arteriovenous (AV) access circuit of hemodialysis patients with either of the two predominant vascular access types - those with an AV graft and those with an AV fistula.

Conditions

  • Restenosis

Interventions

DEVICE

Fluency Plus Endovascular Stent Graft

Treatment of in-stent restenosis

DEVICE

Percutaneous Transluminal Angioplasty only

Treatment of in-stent restenosis

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Abigail Falk, M.D. · Access Center of New Jersey

  • Ivan Maya, MD · Nephrology Associates of Central Florida

  • Alexander Yevzlin, MD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-11-30
Completion
2016-01-31

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 NCT01257438 on ClinicalTrials.gov