Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
35 participants
INTERVENTIONAL
2018-05-14
2020-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Collateral vein ligation
Ligation of collateral veins under sonographic guidance
Collateral vein ligation
Collateral venous flow will be interrupted by ultrasound-guided ligation of venous side branches.
Control
No collateral vein ligation.
No interventions assigned to this group
Interventions
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Collateral vein ligation
Collateral venous flow will be interrupted by ultrasound-guided ligation of venous side branches.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Zubin Irani
Instructor in Inteventional Radiology, Harvard Medical School
Principal Investigators
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Zubin Irani, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Zubin Irani
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Fistula First National Vascular Access Improvements Initiative
Other Identifiers
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2017P001237
Identifier Type: -
Identifier Source: org_study_id