Collateral Ligation in Failing Fistulas

NCT03365089 | Unknown

• 1 other identifier: 2017P001237
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Access Failure

Keywords

Hemodialysis fistula; Failure to mature; Collateral vein

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Collateral vein ligation

EXPERIMENTAL

Ligation of collateral veins under sonographic guidance

Procedure: Collateral vein ligation

Control

NO INTERVENTION

No collateral vein ligation.

Interventions

Collateral vein ligation PROCEDURE

Collateral venous flow will be interrupted by ultrasound-guided ligation of venous side branches.

Collateral vein ligation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (17)

• Sidawy AN, Spergel LM, Besarab A, Allon M, Jennings WC, Padberg FT Jr, Murad MH, Montori VM, O'Hare AM, Calligaro KD, Macsata RA, Lumsden AB, Ascher E; Society for Vascular Surgery. The Society for Vascular Surgery: clinical practice guidelines for the surgical placement and maintenance of arteriovenous hemodialysis access. J Vasc Surg. 2008 Nov;48(5 Suppl):2S-25S. doi: 10.1016/j.jvs.2008.08.042.

  PMID: 19000589 BACKGROUND

• Lok CE. Fistula first initiative: advantages and pitfalls. Clin J Am Soc Nephrol. 2007 Sep;2(5):1043-53. doi: 10.2215/CJN.01080307. Epub 2007 Aug 16. No abstract available.

  PMID: 17702726 BACKGROUND

• Patel ST, Hughes J, Mills JL Sr. Failure of arteriovenous fistula maturation: an unintended consequence of exceeding dialysis outcome quality Initiative guidelines for hemodialysis access. J Vasc Surg. 2003 Sep;38(3):439-45; discussion 445. doi: 10.1016/s0741-5214(03)00732-8.

  PMID: 12947249 BACKGROUND

• Miller PE, Tolwani A, Luscy CP, Deierhoi MH, Bailey R, Redden DT, Allon M. Predictors of adequacy of arteriovenous fistulas in hemodialysis patients. Kidney Int. 1999 Jul;56(1):275-80. doi: 10.1046/j.1523-1755.1999.00515.x.

  PMID: 10411703 BACKGROUND

• Lok CE, Oliver MJ, Su J, Bhola C, Hannigan N, Jassal SV. Arteriovenous fistula outcomes in the era of the elderly dialysis population. Kidney Int. 2005 Jun;67(6):2462-9. doi: 10.1111/j.1523-1755.2005.00355.x.

  PMID: 15882293 BACKGROUND

• Dixon BS, Novak L, Fangman J. Hemodialysis vascular access survival: upper-arm native arteriovenous fistula. Am J Kidney Dis. 2002 Jan;39(1):92-101. doi: 10.1053/ajkd.2002.29886.

  PMID: 11774107 BACKGROUND

• Miller CD, Robbin ML, Allon M. Gender differences in outcomes of arteriovenous fistulas in hemodialysis patients. Kidney Int. 2003 Jan;63(1):346-52. doi: 10.1046/j.1523-1755.2003.00740.x.

  PMID: 12472802 BACKGROUND

• Allon M, Robbin ML. Increasing arteriovenous fistulas in hemodialysis patients: problems and solutions. Kidney Int. 2002 Oct;62(4):1109-24. doi: 10.1111/j.1523-1755.2002.kid551.x.

  PMID: 12234281 BACKGROUND

• Sidawy AN, Gray R, Besarab A, Henry M, Ascher E, Silva M Jr, Miller A, Scher L, Trerotola S, Gregory RT, Rutherford RB, Kent KC. Recommended standards for reports dealing with arteriovenous hemodialysis accesses. J Vasc Surg. 2002 Mar;35(3):603-10. doi: 10.1067/mva.2002.122025.

  PMID: 11877717 BACKGROUND

• Dariushnia SR, Walker TG, Silberzweig JE, Annamalai G, Krishnamurthy V, Mitchell JW, Swan TL, Wojak JC, Nikolic B, Midia M; Society of Interventional Radiology Standards of Practice Committee. Quality Improvement Guidelines for Percutaneous Image-Guided Management of the Thrombosed or Dysfunctional Dialysis Circuit. J Vasc Interv Radiol. 2016 Oct;27(10):1518-30. doi: 10.1016/j.jvir.2016.07.015. Epub 2016 Sep 9. No abstract available.

  PMID: 27622727 BACKGROUND

• Nassar GM. Endovascular management of the "failing to mature" arteriovenous fistula. Tech Vasc Interv Radiol. 2008 Sep;11(3):175-80. doi: 10.1053/j.tvir.2008.09.004.

  PMID: 19100946 BACKGROUND

• Beathard GA, Settle SM, Shields MW. Salvage of the nonfunctioning arteriovenous fistula. Am J Kidney Dis. 1999 May;33(5):910-6. doi: 10.1016/s0272-6386(99)70425-7.

  PMID: 10213648 BACKGROUND

• Han M, Kim JD, Bae JI, Lee JH, Oh CK, Ahn C, Won JH. Endovascular treatment for immature autogenous arteriovenous fistula. Clin Radiol. 2013 Jun;68(6):e309-15. doi: 10.1016/j.crad.2013.01.005. Epub 2013 Mar 5.

  PMID: 23465323 BACKGROUND

• Ahmed O, Patel M, Ginsburg M, Jilani D, Funaki B. Effectiveness of collateral vein embolization for salvage of immature native arteriovenous fistulas. J Vasc Interv Radiol. 2014 Dec;25(12):1890-4. doi: 10.1016/j.jvir.2014.08.015. Epub 2014 Oct 3.

  PMID: 25280664 BACKGROUND

• Cui J, Freed R, Liu F, Irani Z. Interrupting Rivaling Access-flow with Nonsurgical Image-guided ligation: the "IRANI" Procedure. Semin Dial. 2015 Nov-Dec;28(6):E53-7. doi: 10.1111/sdi.12450.

  PMID: 26507374 BACKGROUND

• Turmel-Rodrigues LA. Mechanical enhancement of AVF maturation. J Vasc Access. 2014;15 Suppl 7:S55-9. doi: 10.5301/jva.5000232. Epub 2014 Apr 12.

  PMID: 24817456 BACKGROUND

• Haq NU, Albaqumi M. Accessory vein obliteration criteria for immature fistulae: a modest proposal for an old paradigm. Semin Dial. 2014 Sep-Oct;27(5):E51-4. doi: 10.1111/sdi.12239. Epub 2014 May 6.

  PMID: 24796386 BACKGROUND

Related Links

• Fistula First National Vascular Access Improvements Initiative

Study Officials

• Zubin Irani, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zubin Irani, MD

CONTACT

617-643-0765; zirani@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Inteventional Radiology, Harvard Medical School

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: December 7, 2017
• Study Start: May 14, 2018
• Primary Completion: December 31, 2019
• Study Completion: March 31, 2020
• Last Updated: December 13, 2018

Record last verified: 2018-12

Locations

US (1)