Sirolimus Drug-coated Balloon Versus Stent Graft

NCT05938530 | Recruiting

• 1 other identifier: MOH-CNIG21nov-0008
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A functioning dialysis vascular access is critical to the delivery of lifesaving hemodialysis. Arteriovenous graft (AVG) is a surgically created vascular access used for hemodialysis in patients with end-stage renal disease. AVG thrombosis due to underlying flow-limiting stenosis of the graft vein junction and outflow veins is a common complication. Thrombosed AVG can be treated with thrombolysis combined with percutaneous transluminal angioplasty with good immediate success rates. However, the mid-to-long term patency rates following angioplasty have been suboptimal. Sirolimus drug-coated balloon has been shown to be safe and effective in the salvage of thrombosed arteriovenous graft. The investigators hypothesize that sirolimus drug-coated balloon is non-inferior to stent graft in maintaining the patency of thrombosed AVG that is successfully salvaged. This study is conducted to compare the 6-month access circuit primary patency of thrombosed AVG treated with sirolimus drug-coated balloon versus stent graft.

Conditions

Arteriovenous Shunt Thrombosis; Blood Vessel Prosthesis

Keywords

Arteriovenous graft; Thrombosis; Sirolimus; Drug-coated balloon; stent graft

Outcome Measures

Primary Outcomes (1)

• Access circuit primary patency of AVG at 6-months

  This is measured by the percentage of patients whose AVG remain patent at 6 months after the procedure

  6 months

Secondary Outcomes (6)

• Access circuit primary patency of AVG at 12-months

  12 months

• Target lesion primary patency at 6- and 12-months

  6 and 12 months

• The number of interventions needed to maintain patency of AVG at 12 months

  12 months

• The technical and clinical success rates of the procedures

  Immediately after the procedure

• The complication rates of the procedures

  Immediately after the procedure

Study Arms (2)

Sirolimus drug-coated balloon

EXPERIMENTAL

The trial product is MagicTouch sirolimus drug coated balloon (Concept Medical). Sirolimus will be transferred from the balloon to the graft vein junction by inflating the balloon for 2 minutes at rated burst pressure (typically 12 to 14ATM).

Device: Sirolimus drug-coated balloon

Stent graft

ACTIVE COMPARATOR

Stent graft is the current standard of care for treatment of arteriovenous graft malfunction. A stent graft will be deployed at the graft vein junction.

Device: Stent graft

Interventions

Sirolimus drug-coated balloon DEVICE

The effectiveness of sirolimus coated balloon in patients with dialysis access dysfunction has been shown in a small pilot study in the salvage of thrombosed arteriovenous graft.

Sirolimus drug-coated balloon

Stent graft DEVICE

Stent graft has been shown to be superior than plain balloon angioplasty in the treatment of AVG dysfunction.

Stent graft

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Thrombosed AVG in the upper arm
• Successful thrombolysis of the thrombosed AVG, defined as the re-established of flow on Digital Subtraction Angiography (DSA) and restoration of thrill in the AVG on clinical examination (to be determined during procedure)

You may not qualify if:

• Patient unable to provide informed consent
• Previous bare metal stent or stent-graft placement within the dialysis access
• Previous treatment with DCB within 3 months
• Presence of central vein stenosis which cannot be adequately treated (residual recoil of more than 30%)
• Failure to re-establish blood flow
• Failure to adequately treat the GV junction (defined as residual stenosis of more than 30%)
• Sepsis or active infection
• Recent intracranial bleed or gastrointestinal bleed within the past 12 months
• Allergy to iodinated contrast media, anti-platelet drugs, heparin or sirolimus
• Pregnancy
• Life expectancy \< 12 months based on physician's estimate (eg. active malignancy)

Sponsors & Collaborators

• Singapore General Hospital: lead
• National Medical Research Council (NMRC), Singapore: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

RECRUITING

Related Publications (15)

• 2021 USRDS Annual Data Report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD.

  BACKGROUND

• Singapore Renal Registry Annual Report 2019

  BACKGROUND

• Roy-Chaudhury P, Kelly BS, Miller MA, Reaves A, Armstrong J, Nanayakkara N, Heffelfinger SC. Venous neointimal hyperplasia in polytetrafluoroethylene dialysis grafts. Kidney Int. 2001 Jun;59(6):2325-34. doi: 10.1046/j.1523-1755.2001.00750.x.

  PMID: 11380837 BACKGROUND

• Huber TS, Carter JW, Carter RL, Seeger JM. Patency of autogenous and polytetrafluoroethylene upper extremity arteriovenous hemodialysis accesses: a systematic review. J Vasc Surg. 2003 Nov;38(5):1005-11. doi: 10.1016/s0741-5214(03)00426-9.

  PMID: 14603208 BACKGROUND

• Lee T, Roy-Chaudhury P. Advances and new frontiers in the pathophysiology of venous neointimal hyperplasia and dialysis access stenosis. Adv Chronic Kidney Dis. 2009 Sep;16(5):329-38. doi: 10.1053/j.ackd.2009.06.009.

  PMID: 19695501 BACKGROUND

• Vesely T, DaVanzo W, Behrend T, Dwyer A, Aruny J. Balloon angioplasty versus Viabahn stent graft for treatment of failing or thrombosed prosthetic hemodialysis grafts. J Vasc Surg. 2016 Nov;64(5):1400-1410.e1. doi: 10.1016/j.jvs.2016.04.035. Epub 2016 Jun 25.

  PMID: 27353358 BACKGROUND

• Haskal ZJ, Trerotola S, Dolmatch B, Schuman E, Altman S, Mietling S, Berman S, McLennan G, Trimmer C, Ross J, Vesely T. Stent graft versus balloon angioplasty for failing dialysis-access grafts. N Engl J Med. 2010 Feb 11;362(6):494-503. doi: 10.1056/NEJMoa0902045.

  PMID: 20147715 BACKGROUND

• Haskal ZJ, Saad TF, Hoggard JG, Cooper RI, Lipkowitz GS, Gerges A, Ross JR, Pflederer TA, Mietling SW. Prospective, Randomized, Concurrently-Controlled Study of a Stent Graft versus Balloon Angioplasty for Treatment of Arteriovenous Access Graft Stenosis: 2-Year Results of the RENOVA Study. J Vasc Interv Radiol. 2016 Aug;27(8):1105-1114.e3. doi: 10.1016/j.jvir.2016.05.019. Epub 2016 Jul 4.

  PMID: 27388566 BACKGROUND

• Lok CE, Huber TS, Lee T, Shenoy S, Yevzlin AS, Abreo K, Allon M, Asif A, Astor BC, Glickman MH, Graham J, Moist LM, Rajan DK, Roberts C, Vachharajani TJ, Valentini RP; National Kidney Foundation. KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update. Am J Kidney Dis. 2020 Apr;75(4 Suppl 2):S1-S164. doi: 10.1053/j.ajkd.2019.12.001. Epub 2020 Mar 12.

  PMID: 32778223 BACKGROUND

• Kitrou PM, Katsanos K, Spiliopoulos S, Karnabatidis D, Siablis D. Drug-eluting versus plain balloon angioplasty for the treatment of failing dialysis access: final results and cost-effectiveness analysis from a prospective randomized controlled trial (NCT01174472). Eur J Radiol. 2015 Mar;84(3):418-423. doi: 10.1016/j.ejrad.2014.11.037. Epub 2014 Dec 15.

  PMID: 25575743 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

• Lookstein RA, Haruguchi H, Ouriel K, Weinberg I, Lei L, Cihlar S, Holden A; IN.PACT AV Access Investigators. Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas. N Engl J Med. 2020 Aug 20;383(8):733-742. doi: 10.1056/NEJMoa1914617.

  PMID: 32813949 BACKGROUND

• Liao MT, Lee CP, Lin TT, Jong CB, Chen TY, Lin L, Hsieh MY, Lin MS, Chie WC, Wu CC. A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts. J Vasc Surg. 2020 Jun;71(6):1994-2003. doi: 10.1016/j.jvs.2019.07.090. Epub 2019 Oct 11.

  PMID: 31611105 BACKGROUND

• Tan CW, Tan RY, Pang SC, Tng ARK, Tang TY, Zhuang KD, Chua JME, Tay KH, Chong TT, Tan CS. Single-Center Prospective Pilot Study of Sirolimus Drug-Coated Balloon Angioplasty in Maintaining the Patency of Thrombosed Arteriovenous Graft. J Vasc Interv Radiol. 2021 Mar;32(3):369-375. doi: 10.1016/j.jvir.2020.11.010. Epub 2020 Dec 15.

  PMID: 33334667 BACKGROUND

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ru Yu Tan

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ru Yu Tan

CONTACT

+6563214436; tan.ru.yu@singhealth.com.sg

Study Design

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

Model Details: Participants will be randomly allocated in a 1:1 ratio into either the treatment (sirolimus DCB) arm or control (stent graft) arm

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 10, 2023
• Study Start: November 1, 2023
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)