Collateral Ligation in Failing Fistulas (CLiFF)

May 11, 2026 updated by: Zubin Irani, Massachusetts General Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

- Patients with upper extremity autogenous AVF presenting with FTM with evidence of collaterals on ultrasound and/or clinical exam.

Exclusion criteria:

  • Age under 18 years
  • Pregnant women
  • Prior endovascular or surgical procedure in the fistula after its creation (with the exception of surgical superficialization or mobilization)
  • Clinical evidence of infection associated with the AVF
  • Uncorrectable coagulopathy (International Normalized Radio >2.5, platelet count <50.000/μL)
  • Absence of significant venous side branches on angiogram (defined as those that arise in the initial 10 cm, including the future cannulation zone, and have maximal diameter greater than or equal to one third of the widest diameter of the fistula's main venous channel in this segment).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Collateral vein ligation
Ligation of collateral veins under sonographic guidance
Procedure: Collateral vein ligation
Collateral venous flow will be interrupted by ultrasound-guided ligation of venous side branches.
No Intervention: Control
No collateral vein ligation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
8 weeks after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Zubin Irani, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2018

Primary Completion (Estimated)

December 31, 2019

Study Completion (Estimated)

March 31, 2020

Study Registration Dates

First Submitted

November 21, 2017

First Submitted That Met QC Criteria

December 5, 2017

First Posted (Actual)

December 7, 2017

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017P001237

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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