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Propaten Randomized Investigation on Cost-benefit and Efficacy

NCT01601873 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2019-02-27

Study results available
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Summary

The purpose for this study is to evaluate the patency and outcomes of conventional and heparin anticoagulant bonded arteriovenous grafts in patients with end stage renal disease.

Conditions

  • End-stage Renal Disease

Interventions

DEVICE

PROPATEN

Heparin-bonded graft implantation for hemodialysis vascular access

DEVICE

Standard Graft

non-heparin bonded conventional hemodialysis vascular access graft

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    collaborator OTHER

  • University of Arkansas

    collaborator OTHER

  • Ochsner Health System

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Kristofer M Charlton-Ouw, MD · University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-09
Primary Completion
2017-12-31
Completion
2018-06-30
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 NCT01601873 on ClinicalTrials.gov