Prevention and Treatment of Hemodialysis Vascular Access Malfunction

Study Overview
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Brief Summary
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Vascular access is considered the Achilles heel of the dialysis patient. It constitutes the largest single cause of morbidity in the chronic hemodialysis population, accounting for over 25% of hospitalizations at an estimated cost in the US of at least one billion dollars annually. Currently, complication free survival of vascular access ranges between 30-50% a year and multiple investigative efforts in this area have been initiated and are directed at prolonging the functional life of vascular accesses. It is not well established whether intervention prior to overt malfunction or thrombosis of the vascular access could reduce these complications and thereby improve the functional longevity of the access. Moreover, once accesses at potential risk are identified, it is not well established which method of intervention, Surgery vs. Angioplasty vs. Expectant Management, is superior in terms of clinical and financial outcome. The proposed study aims to determine whether early intervention of a vascular access determined to be at risk of malfunction and thrombosis improves the long term outcome and, specifically, which means of intervention is preferred.

Official Title
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Prevention and Treatment of Hemodialysis Vascular Access Malfunction

Conditions
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End-Stage Renal Disease

Intervention / Treatment
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* Procedure: angioplasty
* Procedure: surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with End Stage Renal Disease on chronic maintenance hemodialysis 3 times per week Have an arteriovenous (polytetrafluoroethylene) graft as vascular access Have a venous stenosis between 30% and 70% as determined by angiogram Exclusion Criteria: Native arteriovenous fistula Known previous vascular accesses complications, such as central vein stenosis, and multiple access surgeries >4 Unwilling to participate Allergy to iodine Absolute contraindication for surgery (e.g. medical condition precludes anesthesia and surgery) Known arterial limb stenosis or long vessel length venous stenosis which are unamenable to surgical or angioplasty techniques, respectively, and therefore prohibit randomization Known hypercoagulable state

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>control group | |
| Active Comparator: 2<br>angioplasty intervention | Procedure: angioplasty<br>* angioplasty performed at the time of the angiogram; approach and technique to be determined by the interventional radiologist<br>|
| Active Comparator: 3<br>surgery intervention | Procedure: surgery<br>* surgical revision of patient's PTFE in a timely fashion not to exceed 72-96 hours after the angiogram; method of revision to be determined by the surgeon performing the procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test the hypothesis that early intervention of a vascular access determined to be at increased risk of malfunction and thrombosis improves the long-term access outcome versus standard of care. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine which means of early intervention, surgery versus angioplasty, is medically and financially advantageous. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESRD, End Stage Renal Disease, Chronic Maintenance Hemodialysis