A Prospective, Randomized Controlled Trial of Stent Graft and Drug Coated Balloon Treatment for Recurrent Cephalic Arch Stenosis in Dysfunctional Arteriovenous-venous Fistula

NCT05360394 | Unknown

• 1 other identifier: 2021/2044
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 2

Brief Summary

Arteriovenous Fistula (AVF) is a surgically created circuit used for hemodialysis in patient with End Stage Renal Disease (ESRD). A functioning dialysis vascular access is critical to the delivery of life-saving hemodialysis (HD) treatment for these patients. Unfortunately, neointimal hyperplasia frequently occurs within the dialysis vascular access, resulting in stenosis, poor flow and thrombosis with loss of function. 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.

Conditions

Neointimal Hyperplasia; Dialysis Access Malfunction

Outcome Measures

Primary Outcomes (2)

• Primary Patency of Target Lesion (Cepahlic Arch)

  Freedom from any re-intervention at target lesion that is clinically driven or indicated on surveillance scan

  6-months post-op

• Primary Patency of Access Circuit

  Percentage of patients who do not need to undergo another re-intervention at the dialysis access circuit

  6-months post-op

Secondary Outcomes (10)

• Primary Patency of Target Lesion

  3 and 12 months post-op

• Primary Patency of Access Circuit

  3 and 12 months post-op

• Assisted Primary Patency of Target Lesion

  3 and 12 months post-op

• Assisted Primary Patency of Access Circuit

  3 and 12 months post-op

• Secondary Patency

  3 and 12 months post-op

Study Arms (2)

PCB Only

ACTIVE COMPARATOR

Cephalic arch stenosis is first treated with conventional plain balloon angioplasty. Once treated adequately (\<30% residual stenosis), CAS will be treated with PCB angioplasty.

Device: Paclitaxel Coated Balloon

Stent Graft and PCB angioplasty of stent edges

EXPERIMENTAL

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.

Device: Paclitaxel Coated Balloon and Stent Graft

Interventions

Paclitaxel Coated Balloon DEVICE

CAS treated with PCB only

PCB Only

Paclitaxel Coated Balloon and Stent Graft DEVICE

CAS treated with PCB first before deployment of stent graft

Stent Graft and PCB angioplasty of stent edges

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 - 90 years
• 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).

You may not qualify if:

• Patient unable to provide informed consent
• 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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (2)

Flinders Medical Center

Adelaide, 5042, Australia

RECRUITING

Singapore General Hospital

Singapore, 169856, Singapore

RECRUITING

Related Publications (8)

• 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.

  PMID: 16565259 BACKGROUND

• 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.

  PMID: 12761309 BACKGROUND

• 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.

  PMID: 33975757 BACKGROUND

• 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.

  PMID: 30040057 BACKGROUND

• 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.

  PMID: 30227772 BACKGROUND

• 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.

  PMID: 18829240 BACKGROUND

• 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.

  PMID: 26074027 BACKGROUND

• 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.

  PMID: 26038628 BACKGROUND

Study Officials

• Tang Tjun Yip

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

• Tan Ru Yu

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

• Tay Kiang Hiong

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charyl Yap

CONTACT

6576 7986; Charyl.yap.j.q@sgh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 4, 2022
• Study Start: April 20, 2022
• Primary Completion: October 1, 2023
• Study Completion: April 1, 2024
• Last Updated: May 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); SG (1)