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Collateral Ligation in Failing Fistulas (CLiFF)

Primary Purpose

Hemodialysis Access Failure

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collateral vein ligation
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemodialysis Access Failure focused on measuring Hemodialysis fistula, Failure to mature, Collateral vein

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Collateral vein ligation

Control

Arm Description

Ligation of collateral veins under sonographic guidance

No collateral vein ligation.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
November 21, 2017
Last Updated
December 11, 2018
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03365089
Brief Title
Collateral Ligation in Failing Fistulas
Acronym
CLiFF
Official Title
Prospective Randomized Evaluation of the Effect of Ligation of Venous Side Branches in Dialysis Arteriovenous Fistulas Presenting With Failure to Mature
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 14, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
March 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis Access Failure
Keywords
Hemodialysis fistula, Failure to mature, Collateral vein

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Collateral vein ligation
Arm Type
Experimental
Arm Description
Ligation of collateral veins under sonographic guidance
Arm Title
Control
Arm Type
No Intervention
Arm Description
No collateral vein ligation.
Intervention Type
Procedure
Intervention Name(s)
Collateral vein ligation
Intervention Description
Collateral venous flow will be interrupted by ultrasound-guided ligation of venous side branches.
Primary Outcome Measure Information:
Title
Fistula maturation rate
Description
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)
Time Frame
8 weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zubin Irani, MD
Phone
617-643-0765
Email
zirani@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zubin Irani, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zubin Irani

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19000589
Citation
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Results Reference
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Citation
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Results Reference
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12947249
Citation
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Citation
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Citation
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Results Reference
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Links:
URL
https://www.esrdncc.org/en/fistula-first-catheter-last
Description
Fistula First National Vascular Access Improvements Initiative

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Collateral Ligation in Failing Fistulas

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