Hemodialysis Access FailureCLiFFNCT03365089
Collateral Ligation in Failing Fistulas
A study testing Collateral vein ligation in people with Hemodialysis Access Failure, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Access Failure
- What is being tested?
- Collateral vein ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2018to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with upper extremity autogenous AVF presenting with FTM with evidence of collaterals on ultrasound and/or clinical exam.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemodialysis Access Failure
- Being tested
- Collateral vein ligation
- Keywords
- Hemodialysis fistula, Failure to mature, Collateral vein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collateral vein ligationProcedure or surgery
Collateral venous flow will be interrupted by ultrasound-guided ligation of venous side branches.
| Study group | Role | What they receive |
|---|---|---|
| Collateral vein ligation | Experimental | Ligation of collateral veins under sonographic guidance Receives: Procedure: Collateral vein ligation |
| Control | No intervention | No collateral vein ligation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 8 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start14 May 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Mar 2020 (estimated)
Why it stopped: no sufficient patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis Access FailureStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zubin Irani, Massachusetts General Hospital
- Investigators
- Zubin Irani, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365089
- Sponsor's protocol ID
- 2017P001237
- Acronym
- CLiFF
- Status last verified
- May 2026
- First submitted
- 21 Nov 2017
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19000589Lok 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.
PubMed 17702726Patel 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.
PubMed 12947249Miller 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.
PubMed 10411703Lok 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.
PubMed 15882293Dixon 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.
PubMed 11774107Miller 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.
PubMed 12472802Allon 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.
PubMed 12234281Sidawy 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.
PubMed 11877717Dariushnia 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.
PubMed 27622727Nassar 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.
PubMed 19100946Beathard 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.
PubMed 10213648Han 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.
PubMed 23465323Ahmed 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.
PubMed 25280664Cui 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.
PubMed 26507374
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Evaluation of the Effect of Ligation of Venous Side Branches in Dialysis Arteriovenous Fistulas Presenting With Failure to Mature
- ClinicalTrials.gov ID
- NCT03365089
- Acronym / sponsor ID
- CLiFF / 2017P001237
- Conditions
- Hemodialysis Access Failure
- Keywords
- Hemodialysis fistula, Failure to mature, Collateral vein
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no sufficient patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 14 May 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collateral vein ligation | Experimental | Procedure: Collateral vein ligationLigation of collateral veins under sonographic guidance |
| Control | No intervention | –No collateral vein ligation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with upper extremity autogenous AVF presenting with FTM with evidence of collaterals on ultrasound and/or clinical exam.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collateral vein ligationCollateral venous flow will be interrupted by ultrasound-guided ligation of venous side branches. | Procedure or surgery | Collateral vein ligation |
Primary outcome
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Background: PubMed 19000589Sidawy 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.
- Background: PubMed 17702726Lok 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.
- Background: PubMed 12947249Patel 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.
- Background: PubMed 10411703Miller 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.
- Background: PubMed 15882293Lok 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.
- Background: PubMed 11774107Dixon 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.
- Background: PubMed 12472802Miller 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.
- Background: PubMed 12234281Allon 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.
- Background: PubMed 11877717Sidawy 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.
- Background: PubMed 27622727Dariushnia 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.
- Background: PubMed 19100946Nassar 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.
- Background: PubMed 10213648Beathard 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.
- Fistula First National Vascular Access Improvements InitiativeLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zubin Irani, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collateral vein ligation in people with Hemodialysis Access Failure, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fistula maturation rate (time frame: 8 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03365089, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.