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NCT03365089 Clinical Trial

Collateral Ligation in Failing Fistulas

Hemodialysis Access Failure Clinical Trial

— CLiFF  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03365089
Other study ID # 2017P001237
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 14, 2018
Est. completion date March 31, 2020

Study information
Verified date December 2018
Source Massachusetts General Hospital
Contact Zubin Irani, MD
Phone 617-643-0765
Email zirani@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

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Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Collateral vein ligation
Collateral venous flow will be interrupted by ultrasound-guided ligation of venous side branches.

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (17)

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Outcome
Type Measure Description Time frame Safety issue
Primary Fistula maturation rate 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) 8 weeks after randomization
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