A Prospective, Randomized Controlled Trial of Stent Graft and Drug Coated Balloon Treatment for Recurrent Cephalic Arch Stenosis in Dysfunctional Arteriovenous-venous Fistula
NCT ID: NCT05360394
Last Updated: 2022-05-04
Study Results
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Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2022-04-20
2024-04-30
Brief Summary
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The cephalic vein forms the outflow conduit for radiocephalic (RC) and brachiocephalic (BC) AVF. At the perpendicular portion of the cephalic vein, the cephalic arch is often prone to developing hemodynamically significant stenosis. The prevalence of cephalic arch stenosis is reported to be 39% in brachiocepahlic and 2% in radiocephalic AVF.
The current gold standard therapy for treatment of AVF stenosis is plain balloon angioplasty (BA). Paclitaxel coated balloon (PCB) angioplasty has also been shown recently to be superior to plain BA in the treatment of stenosis in dialysis vascular access. By releasing paclitaxel, which is an anti-proliferation drug, locally into the vessel wall during balloon contact, it will blunt the acceleration of intimal hyperplasia response, resulting in improved primary patency after angioplasty.
The use of stent grafts for recurrent CAS has been demonstrated to increase patency of AVF compared to BA and bare stents. However, stent grafts are prone to edge restenosis that tend to occur within 5mm of each end of SG due to neointimal hyperplasia from the end of the stent migrating towards the center. We postulate that stent graft with PCB angioplasty of the stent edge is more effective than PCB alone in maintaining the patency of AVF with cephalic arch stenosis.
Therefore, we aim to perform a randomized controlled trial to compare the 6-month unassisted patency rate of treatment of recurrent CAS with stent graft and PCB angioplasty of both stent edge versus PCB alone.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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PCB Only
Cephalic arch stenosis is first treated with conventional plain balloon angioplasty. Once treated adequately (\<30% residual stenosis), CAS will be treated with PCB angioplasty.
Paclitaxel Coated Balloon
CAS treated with PCB only
Stent Graft and PCB angioplasty of stent edges
CAS is first treated with conventional plain balloon angioplasty. Once treated adequately (\<30% residual stenosis), CAS will be treated with PCB first to avoid geographical miss. After which, stent graft will be deployed. Length of PCB shall be long enough to cover stent edges.
Paclitaxel Coated Balloon and Stent Graft
CAS treated with PCB first before deployment of stent graft
Interventions
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Paclitaxel Coated Balloon
CAS treated with PCB only
Paclitaxel Coated Balloon and Stent Graft
CAS treated with PCB first before deployment of stent graft
Eligibility Criteria
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Inclusion Criteria
* Patients who requires balloon angioplasty for dysfunctional arteriovenous fistula, can be de novo lesions or recurrent CAS stenosis within six months of interventions. Suitability will be determined with a baseline ultrasound assessment.
* Matured AVF, defined as being in use for at least 1 month prior to angioplasty
* Successful angioplasty of the underlying stenosis, defined as less than 30% residual stenosis on Digital Subtraction Angiography (DSA).
Exclusion Criteria
* Thrombosed or partially thrombosed AVF
* Immature AVF
* Insignificant CAS defined as \<50% stenosis and no clinical indicator such as high V pressure.
* Presence of central vein stenosis with more than 30% residual stenosis post-angioplasty
* Patient who had underwent stent placement within the CAS previously
* Patients who are allergic to both aspirin or clopidogrel
* Patient who are currently enrolled in other drug eluting balloon trials
* Sepsis or active infection
* Recent intracranial bleed or gastrointestinal bleed within the past 12 months.
* Allergy to iodinated contrast media, heparin or paclitaxel
* Pregnancy
21 Years
90 Years
ALL
No
Sponsors
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Singapore General Hospital
OTHER
Responsible Party
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Principal Investigators
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Tang Tjun Yip
Role: PRINCIPAL_INVESTIGATOR
Singapore General Hospital
Tan Ru Yu
Role: PRINCIPAL_INVESTIGATOR
Singapore General Hospital
Tay Kiang Hiong
Role: PRINCIPAL_INVESTIGATOR
Singapore General Hospital
Locations
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Flinders Medical Center
Adelaide, , Australia
Singapore General Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Chris Delaney
Role: primary
References
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Roy-Chaudhury P, Sukhatme VP, Cheung AK. Hemodialysis vascular access dysfunction: a cellular and molecular viewpoint. J Am Soc Nephrol. 2006 Apr;17(4):1112-27. doi: 10.1681/ASN.2005050615.
Rajan DK, Clark TW, Patel NK, Stavropoulos SW, Simons ME. Prevalence and treatment of cephalic arch stenosis in dysfunctional autogenous hemodialysis fistulas. J Vasc Interv Radiol. 2003 May;14(5):567-73. doi: 10.1097/01.rvi.0000071090.76348.bc.
Trerotola SO, Roy-Chaudhury P, Saad TF. Drug-Coated Balloon Angioplasty in Failing Arteriovenous Fistulas: More Data, Less Clarity. Am J Kidney Dis. 2021 Jul;78(1):13-15. doi: 10.1053/j.ajkd.2021.02.331. Epub 2021 May 8. No abstract available.
Irani FG, Teo TKB, Tay KH, Yin WH, Win HH, Gogna A, Patel A, Too CW, Chan SXJM, Lo RHG, Toh LHW, Chng SP, Choong HL, Tan BS. Hemodialysis Arteriovenous Fistula and Graft Stenoses: Randomized Trial Comparing Drug-eluting Balloon Angioplasty with Conventional Angioplasty. Radiology. 2018 Oct;289(1):238-247. doi: 10.1148/radiol.2018170806. Epub 2018 Jul 24.
Swinnen JJ, Hitos K, Kairaitis L, Gruenewald S, Larcos G, Farlow D, Huber D, Cassorla G, Leo C, Villalba LM, Allen R, Niknam F, Burgess D. Multicentre, randomised, blinded, control trial of drug-eluting balloon vs Sham in recurrent native dialysis fistula stenoses. J Vasc Access. 2019 May;20(3):260-269. doi: 10.1177/1129729818801556. Epub 2018 Sep 18.
Shemesh D, Goldin I, Zaghal I, Berlowitz D, Raveh D, Olsha O. Angioplasty with stent graft versus bare stent for recurrent cephalic arch stenosis in autogenous arteriovenous access for hemodialysis: a prospective randomized clinical trial. J Vasc Surg. 2008 Dec;48(6):1524-31, 1531.e1-2. doi: 10.1016/j.jvs.2008.07.071. Epub 2008 Oct 1.
Rajan DK, Falk A. A Randomized Prospective Study Comparing Outcomes of Angioplasty versus VIABAHN Stent-Graft Placement for Cephalic Arch Stenosis in Dysfunctional Hemodialysis Accesses. J Vasc Interv Radiol. 2015 Sep;26(9):1355-61. doi: 10.1016/j.jvir.2015.05.001.
Ginsburg M, Lorenz JM, Zivin SP, Zangan S, Martinez D. A practical review of the use of stents for the maintenance of hemodialysis access. Semin Intervent Radiol. 2015 Jun;32(2):217-24. doi: 10.1055/s-0035-1549844. No abstract available.
Other Identifiers
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2021/2044
Identifier Type: -
Identifier Source: org_study_id
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