Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene (ePTFE) Vascular Access Grafts

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-11-30

Brief Summary

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The purpose of this study is to establish the substantial equivalence of Expedial and ePTFE grafts for effectiveness in maintaining primary or assisted primary patency.

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Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Expedial Vascular Access Graft

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient has chronic renal failure and requires vascular access for hemodialysis
* Patient has given informed consent to participate in the trial and is willing to comply with the study protocol
* Patient is male or female, 18 years of age or older
* The vascular access graft can be placed in the upper extremity (forearm, including across the elbow, or upper arm)
* Patient is undergoing or will undergo hemodialysis at a hospital or hemodialysis center
* Patient has a vein 4 mm or larger to which the graft can be anastomosed

Exclusion Criteria

* Patient is unable to comply with the study follow-up
* Patient has a known sensitivity to polyurethane or porcine heparin
* Patient has a previous vascular access graft implanted and it is not possible to place the study graft proximal to the existing device and no other sites are available
* Patient has an immunodeficiency syndrome
* Patient has a prior history of bacterial infection within 8 weeks of implantation of graft
* Patient has a severe coagulation disorder
* Patient has an elevated platelet count of greater than 1 million
* Patient has a history of heparin-induced thrombocytopenia syndrome (HIT)
* Patient is pregnant
* Patient has a fever greater than 100 degrees Fahrenheit

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No