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Clinical Trials/NCT03365089
NCT03365089
Unknown
Not Applicable

Prospective Randomized Evaluation of the Effect of Ligation of Venous Side Branches in Dialysis Arteriovenous Fistulas Presenting With Failure to Mature

Massachusetts General Hospital1 site in 1 country35 target enrollmentMay 14, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemodialysis Access Failure
Sponsor
Massachusetts General Hospital
Enrollment
35
Locations
1
Primary Endpoint
Fistula maturation rate
Last Updated
7 years ago

Overview

Brief Summary

Arteriovenous fistulas (AVFs) for hemodialysis often fail to become usable due to failure to mature (FTM). The most common cause is narrowing of the artery or vein (stenosis). Another potential cause is the presence of collateral or side branch veins that steal blood flow from the main fistula channel. Some believe that occluding these veins might help maturation of those failing AVFs. To evaluate if this actually works, patients with FTM will be randomly assigned to side branch vein ligation (or not), and rates of AVF maturation of the two groups will be compared.

Detailed Description

Arteriovenous fistulas (AVFs) for hemodialysis often fail to become usable due to failure to mature (FTM). The most common cause is stenosis of the artery or vein. Another potential cause is the presence of collateral or side branch veins that steal blood flow from the main fistula channel. The utility of ligating these veins to improve maturation of those failing AVFs is controversial. To evaluate this, 35 patients presenting for fistulograms for evaluation of AVFs with FTM, found to have side branch veins will be prospectively enrolled. After management of stenoses (if present), they will be randomly assigned to ligation of the venous side branches or not. Maturation rates for each group will be prospectively assessed. For patients assigned to the control group who have persistent failure to mature, a cross-over intervention will be performed and side branch ligation will be offered.

Registry
clinicaltrials.gov
Start Date
May 14, 2018
End Date
March 31, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zubin Irani

Instructor in Inteventional Radiology, Harvard Medical School

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Fistula maturation rate

Time Frame: 8 weeks after randomization

Proportion of patients with usable arteriovenous fistula at the end of the study (being able to deliver the prescribed dialysis dose 75% of the sessions in the first 4 weeks of use via 2 needles)

Study Sites (1)

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