Collateral Ligation in Failing Fistulas

Last updated: December 11, 2018
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03365089
2017P001237
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Patients with upper extremity autogenous AVF presenting with FTM with evidence ofcollaterals on ultrasound and/or clinical exam.

Exclusion

Exclusion criteria:

  • Age under 18 years

  • Pregnant women

  • Prior endovascular or surgical procedure in the fistula after its creation (with theexception 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 arisein the initial 10 cm, including the future cannulation zone, and have maximal diametergreater than or equal to one third of the widest diameter of the fistula's main venouschannel in this segment).

Study Design

Total Participants: 35
Study Start date:
May 14, 2018
Estimated Completion Date:
March 31, 2020

Study 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.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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