A Real-world Registry Investigating Sirolimus-coated Balloon Versus Paclitaxel-coated Balloon Angioplasty for the Treatment of Dysfunctional Arteriovenous Fistula

NCT05333640 | Unknown

• 1 other identifier: 2022/2014
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Drug-coated balloon (DCB) angioplasty has been shown to be superior to POBA in the treatment of stenosis in AVF. This is because the very intervention used to treat underlying stenosis by POBA can induce vascular injury and accelerate intimal hyperplasia, resulting in rapid restenosis and need for repeated procedure to maintain vessel patency. The anti-proliferative drug that is coated on the surface of balloon is released to the vessel wall during balloon angioplasty and blunt the acceleration of intimal hyperplasia response, resulting in improved primary patency after angioplasty. Additionally, unlike stents, DCB does not leave a permanent structure that may impede future surgical revision. Recent randomized control trials (RCT) have shown the superiority of paclitaxel durg-coated balloon (PDCB) over POBA in the treatment of stenosis in AVFs. In a large multicenter RCT, PDCB was demonstrated to result in a 6-month target lesion primary patency of 82.2% compared to 59.5% for POBA. However, concerns had also arisen recently in the use of PDCB. In large lower limb studies involving the use of paclitaxel devices, meta-analysis by Katsanos et al had revealed increased late risk mortality in patient that are treated with PDCB or paclitaxel-coated stent. Sirolimus drug-coated balloon (SDCB) is the new generation of drug eluting balloons that are available in the market. Compared to paclitaxel, sirolimus is cytostatic in its mode of action with a high margin of safety. It has a high transfer rate to the vessel wall and effectively inhibit neointimal hyperplasia in the porcine coronary model. The effectiveness of SDCB in patients with dialysis access dysfunction has been shown in a small pilot study in AVF stenosis and AVG thrombosis. SAVE AVF registry ams to assess the efficacy and safety of SDCB vs PDCB angioplasty.

Conditions

Dialysis Access Malfunction; Stenosis

Outcome Measures

Primary Outcomes (1)

• Circuit Primary Patency Rate at 6 months

  Circuit primary patency is lost if patient has to undergo a repeat intervention that is clinically driven. Clinically driven indication may be based on physical examination such as loss of thrill, pulsatile flow or swollen arm.

  6 months post-op

Secondary Outcomes (7)

• Circuit Primary Patency at 12 months

  12 months post-op

• Target Lesion Restenosis

  6 and 12 months post-op

• Number of repeat interventions to treated lesion

  6 and 12 months post-op

• Number of repeat interventions to maintain access circuit

  6 and 12 months post-op

• Target lesion revascularization free interval

  12 months post-op

Study Arms (2)

AVFs treated with Sirolimus Drug Coated Balloon

Dysfunctional matured AVF that have underwent thrombolysis or balloon angioplasty with SDCB within 6 months witll be considered for the registry.

Device: Sirolimus Drug Coated Balloon

AVFs treated with Paclitaxel Drug Coated Balloon

Dysfunctional matured AVF that have underwent thrombolysis or balloon angioplasty with PDCB within 6 months witll be considered for the registry.

Device: Paclitaxel Drug Coated Balloon

Interventions

Sirolimus Drug Coated Balloon DEVICE

AVFs treated with SDCB

AVFs treated with Sirolimus Drug Coated Balloon

Paclitaxel Drug Coated Balloon DEVICE

AVFs treated with PDCB

AVFs treated with Paclitaxel Drug Coated Balloon

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with dysfunctional AVFs who have undergone balloon angioplasty or thrombolysis with PDCB or SDCB.

You may qualify if:

• Age 21-85 years
• Patient who required balloon angioplasty for dysfunctional or thrombosed AVF
• Successful thrombolysis and angioplasty of the underlying stenosis, defined as less than 30% residual stenosis on Digital Subtraction Angiography (DSA) based on visual assessment of the operator and restoration of thrill in the AVF on clinical examination. For concurrent asymptomatic or angiographically not significant central vein stenosis, patients can be included in no treatment is required.
• received either PDCB or SDCB for the treatment of stenosis.

You may not qualify if:

• Patient unable to provide informed consent
• Presence of symptomatic or angiographically significant central vein stenosis who require treatment, with more than 30% residual stenosis post angioplasty
• Patients who had underwent stent placement within the AVF circuit
• Sepsis or active infection
• Recent intracranial bleed or gastrointestinal bleed within the past 12 months.
• Allergy to iodinated contrast media, heparin, paclitaxel or sirolimus
• Pregnancy
• Inadequate treatment of underlying stenosis, defined as \>= 30% residual stenosis of the underlying lesions.

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169856, Singapore

RECRUITING

Related Publications (16)

• 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

• 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

• Pantelias K, Grapsa E. Vascular access today. World J Nephrol. 2012 Jun 6;1(3):69-78. doi: 10.5527/wjn.v1.i3.69.

  PMID: 24175244 BACKGROUND

• Rajan DK, Bunston S, Misra S, Pinto R, Lok CE. Dysfunctional autogenous hemodialysis fistulas: outcomes after angioplasty--are there clinical predictors of patency? Radiology. 2004 Aug;232(2):508-15. doi: 10.1148/radiol.2322030714.

  PMID: 15286321 BACKGROUND

• Manninen HI, Kaukanen ET, Ikaheimo R, Karhapaa P, Lahtinen T, Matsi P, Lampainen E. Brachial arterial access: endovascular treatment of failing Brescia-Cimino hemodialysis fistulas--initial success and long-term results. Radiology. 2001 Mar;218(3):711-8. doi: 10.1148/radiology.218.3.r01mr38711.

  PMID: 11230644 BACKGROUND

• Heye S, Maleux G, Vaninbroukx J, Claes K, Kuypers D, Oyen R. Factors influencing technical success and outcome of percutaneous balloon angioplasty in de novo native hemodialysis arteriovenous fistulas. Eur J Radiol. 2012 Sep;81(9):2298-303. doi: 10.1016/j.ejrad.2011.09.004. Epub 2011 Sep 28.

  PMID: 21955605 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

• 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

• Salman L, Asif A. Stent graft for nephrologists: concerns and consensus. Clin J Am Soc Nephrol. 2010 Jul;5(7):1347-52. doi: 10.2215/CJN.02380310. Epub 2010 May 27.

  PMID: 20507955 BACKGROUND

• Allon M. Current management of vascular access. Clin J Am Soc Nephrol. 2007 Jul;2(4):786-800. doi: 10.2215/CJN.00860207. Epub 2007 May 30.

  PMID: 17699495 BACKGROUND

• Katsanos K, Karnabatidis D, Kitrou P, Spiliopoulos S, Christeas N, Siablis D. Paclitaxel-coated balloon angioplasty vs. plain balloon dilation for the treatment of failing dialysis access: 6-month interim results from a prospective randomized controlled trial. J Endovasc Ther. 2012 Apr;19(2):263-72. doi: 10.1583/11-3690.1.

  PMID: 22545894 BACKGROUND

• Kennedy SA, Mafeld S, Baerlocher MO, Jaberi A, Rajan DK. Drug-Coated Balloon Angioplasty in Hemodialysis Circuits: A Systematic Review and Meta-Analysis. J Vasc Interv Radiol. 2019 Apr;30(4):483-494.e1. doi: 10.1016/j.jvir.2019.01.012. Epub 2019 Mar 8.

  PMID: 30857987 BACKGROUND

• Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. 2018 Dec 18;7(24):e011245. doi: 10.1161/JAHA.118.011245.

  PMID: 30561254 BACKGROUND

• Clever YP, Peters D, Calisse J, Bettink S, Berg MC, Sperling C, Stoever M, Cremers B, Kelsch B, Bohm M, Speck U, Scheller B. Novel Sirolimus-Coated Balloon Catheter: In Vivo Evaluation in a Porcine Coronary Model. Circ Cardiovasc Interv. 2016 Apr;9(4):e003543. doi: 10.1161/CIRCINTERVENTIONS.115.003543.

  PMID: 27069105 BACKGROUND

• Verheye S, Vrolix M, Kumsars I, Erglis A, Sondore D, Agostoni P, Cornelis K, Janssens L, Maeng M, Slagboom T, Amoroso G, Jensen LO, Granada JF, Stella P. The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis): Angiographic Results and 1-Year Clinical Outcomes. JACC Cardiovasc Interv. 2017 Oct 23;10(20):2029-2037. doi: 10.1016/j.jcin.2017.06.021. Epub 2017 Sep 27.

  PMID: 28964764 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

Related Links

• Trends in Chronic Kidney Failure Stage 5 in Singapore 2013/2013
• Updated CIRSE Position Statement on the use of Paclitaxel-Coated Balloons and Stents in Peripheral Arterial Disease.

MeSH Terms

Conditions

Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Tjun Tip Tang

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

• Ru Yu Tan

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

• Apoorva Gogna

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charyl Yap

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 19, 2022
• Study Start: April 18, 2022
• Primary Completion: October 30, 2023
• Study Completion: April 30, 2024
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)