Clinical trial NCT05654103 - References

End Stage Renal Disease on Dialysis — Comparing Surgical and Endovascular Arteriovenous Fistula Creation

Citation(s)

•   Al-Jaishi AA, Oliver MJ, Thomas SM, Lok CE, Zhang JC, Garg AX, Kosa SD, Quinn RR, Moist LM
  Patency rates of the arteriovenous fistula for hemodialysis: a systematic review and meta-analysis. Am J Kidney Dis. 2014 Mar;63(3):464-78. doi: 10.1053/j.ajkd.2013.08.023. Epub 2013 Oct 30.
•   Beathard GA, Lok CE, Glickman MH, Al-Jaishi AA, Bednarski D, Cull DL, Lawson JH, Lee TC, Niyyar VD, Syracuse D, Trerotola SO, Roy-Chaudhury P, Shenoy S, Underwood M, Wasse H, Woo K, Yuo TH, Huber TS
  Definitions and End Points for Interventional Studies for Arteriovenous Dialysis Access. Clin J Am Soc Nephrol. 2018 Mar 7;13(3):501-512. doi: 10.2215/CJN.11531116. Epub 2017 Jul 20.
•   Beaulieu RJ, Locham S, Nejim B, Dakour-Aridi H, Woo K, Malas MB
  General anesthesia is associated with reduced early failure among patients undergoing hemodialysis access. J Vasc Surg. 2019 Mar;69(3):890-897.e5. doi: 10.1016/j.jvs.2018.05.247.
•   Belin TR, Gjertson DW, Hu MY
  Summarizing DNA evidence when relatives are possible suspects. Journal of the American Statistical Association 1997;92:706-16.
•   Berland TL, Clement J, Griffin J, Westin GG, Ebner A
  Endovascular Creation of Arteriovenous Fistulae for Hemodialysis Access with a 4 Fr Device: Clinical Experience from the EASE Study. Ann Vasc Surg. 2019 Oct;60:182-192. doi: 10.1016/j.avsg.2019.02.023. Epub 2019 May 8.
•   Braun V, Clarke V
  Using thematic analysis in psychology. Qualitative research in psychology 2006;3:77-101.
•   Brescia MJ, Cimino JE, Appell K, Hurwich BJ, Scribner BH
  Chronic hemodialysis using venipuncture and a surgically created arteriovenous fistula. 1966. J Am Soc Nephrol. 1999 Jan;10(1):193-9. No abstract available.
•   Cassileth BR, Lusk EJ, Miller DS, Hurwitz S
  Attitudes toward clinical trials among patients and the public. JAMA. 1982 Aug 27;248(8):968-70.
•   Cella D, Choi SW, Condon DM, Schalet B, Hays RD, Rothrock NE, Yount S, Cook KF, Gershon RC, Amtmann D, DeWalt DA, Pilkonis PA, Stone AA, Weinfurt K, Reeve BB
  PROMIS(R) Adult Health Profiles: Efficient Short-Form Measures of Seven Health Domains. Value Health. 2019 May;22(5):537-544. doi: 10.1016/j.jval.2019.02.004.
•   Cheung AK, Imrey PB, Alpers CE, Robbin ML, Radeva M, Larive B, Shiu YT, Allon M, Dember LM, Greene T, Himmelfarb J, Roy-Chaudhury P, Terry CM, Vazquez MA, Kusek JW, Feldman HI; Hemodialysis Fistula Maturation Study Group
  Intimal Hyperplasia, Stenosis, and Arteriovenous Fistula Maturation Failure in the Hemodialysis Fistula Maturation Study. J Am Soc Nephrol. 2017 Oct;28(10):3005-3013. doi: 10.1681/ASN.2016121355. Epub 2017 Jul 14.
•   Dember LM, Beck GJ, Allon M, Delmez JA, Dixon BS, Greenberg A, Himmelfarb J, Vazquez MA, Gassman JJ, Greene T, Radeva MK, Braden GL, Ikizler TA, Rocco MV, Davidson IJ, Kaufman JS, Meyers CM, Kusek JW, Feldman HI; Dialysis Access Consortium Study Group
  Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial. JAMA. 2008 May 14;299(18):2164-71. doi: 10.1001/jama.299.18.2164.
•   Domenick Sridharan N, Fish L, Yu L, Weisbord S, Jhamb M, Makaroun MS, Yuo TH
  The associations of hemodialysis access type and access satisfaction with health-related quality of life. J Vasc Surg. 2018 Jan;67(1):229-235. doi: 10.1016/j.jvs.2017.05.131. Epub 2017 Aug 16.
•   Fallowfield LJ, Jenkins V, Brennan C, Sawtell M, Moynihan C, Souhami RL
  Attitudes of patients to randomised clinical trials of cancer therapy. Eur J Cancer. 1998 Sep;34(10):1554-9. doi: 10.1016/s0959-8049(98)00193-2.
•   Farber A, Imrey PB, Huber TS, Kaufman JM, Kraiss LW, Larive B, Li L, Feldman HI; HFM Study Group
  Multiple preoperative and intraoperative factors predict early fistula thrombosis in the Hemodialysis Fistula Maturation Study. J Vasc Surg. 2016 Jan;63(1):163-70.e6. doi: 10.1016/j.jvs.2015.07.086.
•   Franco G, Mallios A, Bourquelot P, Hebibi H, Jennings W, Boura B
  Feasibility for arteriovenous fistula creation with Ellipsys(R). J Vasc Access. 2020 Sep;21(5):701-704. doi: 10.1177/1129729819900114. Epub 2020 Jan 13.
•   Gayet-Ageron A, Rudaz S, Perneger T
  Study design factors influencing patients' willingness to participate in clinical research: a randomised vignette-based study. BMC Med Res Methodol. 2020 Apr 26;20(1):93. doi: 10.1186/s12874-020-00979-z.
•   Harika G, Mallios A, Allouache M, Costanzo A, de Blic R, Boura B, Jennings WC
  Comparison of surgical versus percutaneously created arteriovenous hemodialysis fistulas. J Vasc Surg. 2021 Jul;74(1):209-216. doi: 10.1016/j.jvs.2020.12.086. Epub 2021 Feb 4.
•   Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium
  The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.
•   Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG
  Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
•   Hull JE, Elizondo-Riojas G, Bishop W, Voneida-Reyna YL
  Thermal Resistance Anastomosis Device for the Percutaneous Creation of Arteriovenous Fistulae for Hemodialysis. J Vasc Interv Radiol. 2017 Mar;28(3):380-387. doi: 10.1016/j.jvir.2016.10.033. Epub 2016 Dec 29.
•   Inston N, Khawaja A, Tullett K, Jones R
  WavelinQ created arteriovenous fistulas versus surgical radiocephalic arteriovenous fistulas? A single-centre observational study. J Vasc Access. 2020 Sep;21(5):646-651. doi: 10.1177/1129729819897168. Epub 2020 Jan 2.
•   Jenkins V, Farewell V, Farewell D, Darmanin J, Wagstaff J, Langridge C, Fallowfield L; TTT Steering committee
  Drivers and barriers to patient participation in RCTs. Br J Cancer. 2013 Apr 16;108(7):1402-7. doi: 10.1038/bjc.2013.113. Epub 2013 Mar 19.
•   Jones RG, Morgan RA
  A Review of the Current Status of Percutaneous Endovascular Arteriovenous Fistula Creation for Haemodialysis Access. Cardiovasc Intervent Radiol. 2019 Jan;42(1):1-9. doi: 10.1007/s00270-018-2037-6. Epub 2018 Jul 20.
•   Kim JJ, Gifford E, Nguyen V, Kaji AH, Chisum P, Zeng A, Dukkipati R, de Virgilio C
  Increased use of brachiocephalic arteriovenous fistulas improves functional primary patency. J Vasc Surg. 2015 Aug;62(2):442-7. doi: 10.1016/j.jvs.2015.03.019. Epub 2015 Apr 30.
•   Lee T, Qian JZ, Zhang Y, Thamer M, Allon M
  Long-Term Outcomes of Arteriovenous Fistulas with Unassisted versus Assisted Maturation: A Retrospective National Hemodialysis Cohort Study. J Am Soc Nephrol. 2019 Nov;30(11):2209-2218. doi: 10.1681/ASN.2019030318. Epub 2019 Oct 14.
•   Lee T, Thamer M, Zhang Y, Zhang Q, Allon M
  Outcomes of Elderly Patients after Predialysis Vascular Access Creation. J Am Soc Nephrol. 2015 Dec;26(12):3133-40. doi: 10.1681/ASN.2014090938. Epub 2015 Apr 8.
•   Lim CT, Roberts HJ, Collins JE, Losina E, Katz JN
  Factors influencing the enrollment in randomized controlled trials in orthopedics. Contemp Clin Trials Commun. 2017 Oct 16;8:203-208. doi: 10.1016/j.conctc.2017.10.005. eCollection 2017 Dec.
•   Lin SL, Huang CH, Chen HS, Hsu WA, Yen CJ, Yen TS
  Effects of age and diabetes on blood flow rate and primary outcome of newly created hemodialysis arteriovenous fistulas. Am J Nephrol. 1998;18(2):96-100. doi: 10.1159/000013315.
•   Liu M, Taylor JM, Belin TR
  Multiple imputation and posterior simulation for multivariate missing data in longitudinal studies. Biometrics. 2000 Dec;56(4):1157-63. doi: 10.1111/j.0006-341x.2000.01157.x.
•   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. Erratum In: Am J Kidney Dis. 2021 Apr;77(4):551.
•   Lok CE, Rajan DK, Clement J, Kiaii M, Sidhu R, Thomson K, Buldo G, Dipchand C, Moist L, Sasal J; NEAT Investigators
  Endovascular Proximal Forearm Arteriovenous Fistula for Hemodialysis Access: Results of the Prospective, Multicenter Novel Endovascular Access Trial (NEAT). Am J Kidney Dis. 2017 Oct;70(4):486-497. doi: 10.1053/j.ajkd.2017.03.026. Epub 2017 Jun 14.
•   Mallios A, Bourquelot P, Franco G, Hebibi H, Fonkoua H, Allouache M, Costanzo A, de Blic R, Harika G, Boura B, Jennings WC
  Midterm results of percutaneous arteriovenous fistula creation with the Ellipsys Vascular Access System, technical recommendations, and an algorithm for maintenance. J Vasc Surg. 2020 Dec;72(6):2097-2106. doi: 10.1016/j.jvs.2020.02.048. Epub 2020 Apr 8.
•   Mallios A, Jennings WC, Boura B, Costanzo A, Bourquelot P, Combes M
  Early results of percutaneous arteriovenous fistula creation with the Ellipsys Vascular Access System. J Vasc Surg. 2018 Oct;68(4):1150-1156. doi: 10.1016/j.jvs.2018.01.036. Epub 2018 Apr 19.
•   Malovrh M
  Native arteriovenous fistula: preoperative evaluation. Am J Kidney Dis. 2002 Jun;39(6):1218-25. doi: 10.1053/ajkd.2002.33394.
•   Menard MT, Farber A, Assmann SF, Choudhry NK, Conte MS, Creager MA, Dake MD, Jaff MR, Kaufman JA, Powell RJ, Reid DM, Siami FS, Sopko G, White CJ, Rosenfield K
  Design and Rationale of the Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia (BEST-CLI) Trial. J Am Heart Assoc. 2016 Jul 8;5(7):e003219. doi: 10.1161/JAHA.116.003219.
•   Mordhorst A, Clement J, Kiaii M, Faulds J, Hsiang Y, Misskey J
  A comparison of outcomes between open and endovascular arteriovenous access creation for hemodialysis. J Vasc Surg. 2022 Jan;75(1):238-247.e1. doi: 10.1016/j.jvs.2021.07.104. Epub 2021 Jul 22.
•   Neumann ME
  "Fistula first" initiative pushes for new standards in access care. Nephrol News Issues. 2004 Aug;18(9):43, 47-8. No abstract available.
•   Nordyke RJ, Nicholson G, Gage SM, Lithgow T, Himmelfarb J, Rivara MB, Hays RD, Woo K, Peipert JD
  Vascular access-specific health-related quality of life impacts among hemodialysis patients: qualitative development of the hemodialysis access-related quality of life (HARQ) instrument. BMC Nephrol. 2020 Jan 14;21(1):16. doi: 10.1186/s12882-020-1683-5.
•   Osofsky R, Byrd D, Reagor J, Das Gupta J, Clark R, Argyropoulos C, Fabre A, Owen J, Marek J, Rana MA, Langsfeld M, Chavez L
  Initial Outcomes Following Introduction of Percutaneous Arteriovenous Fistula Program with Comparison to Historical Surgically Created Fistulas. Ann Vasc Surg. 2021 Jul;74:271-280. doi: 10.1016/j.avsg.2020.12.041. Epub 2021 Feb 4.
•   Penman DT, Holland JC, Bahna GF, Morrow G, Schmale AH, Derogatis LR, Carnrike CL Jr, Cherry R
  Informed consent for investigational chemotherapy: patients' and physicians' perceptions. J Clin Oncol. 1984 Jul;2(7):849-55. doi: 10.1200/JCO.1984.2.7.849.
•   Robbin ML, Chamberlain NE, Lockhart ME, Gallichio MH, Young CJ, Deierhoi MH, Allon M
  Hemodialysis arteriovenous fistula maturity: US evaluation. Radiology. 2002 Oct;225(1):59-64. doi: 10.1148/radiol.2251011367.
•   Rubin DB
  Multiple imputation for nonresponse in surveys: John Wiley & Sons; 2004.
•   Sandelowski M
  Sample size in qualitative research. Res Nurs Health. 1995 Apr;18(2):179-83. doi: 10.1002/nur.4770180211.
•   Schafer JL
  Analysis of incomplete multivariate data: CRC press; 1997.
•   Shahverdyan R, Beathard G, Mushtaq N, Litchfield TF, Vartanian S, Konner K, Jennings WC
  Comparison of Ellipsys Percutaneous and Proximal Forearm Gracz-Type Surgical Arteriovenous Fistulas. Am J Kidney Dis. 2021 Oct;78(4):520-529.e1. doi: 10.1053/j.ajkd.2021.01.011. Epub 2021 Mar 1.
•   Sibai T, Carlisle H, Tornetta P 3rd
  The darker side of randomized trials: recruitment challenges. J Bone Joint Surg Am. 2012 Jul 18;94 Suppl 1:49-55. doi: 10.2106/JBJS.L.00240.
•   Sidawy 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.
•   Tong A, Sainsbury P, Craig J
  Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007 Dec;19(6):349-57. doi: 10.1093/intqhc/mzm042. Epub 2007 Sep 14.
•   Vascular Access Work Group
  Clinical practice guidelines for vascular access. Am J Kidney Dis. 2006 Jul;48 Suppl 1:S248-73. doi: 10.1053/j.ajkd.2006.04.040. No abstract available.
•   Viecelli AK, O'Lone E, Sautenet B, Craig JC, Tong A, Chemla E, Hooi LS, Lee T, Lok C, Polkinghorne KR, Quinn RR, Vachharajani T, Vanholder R, Zuo L, Irish AB, Mori TA, Pascoe EM, Johnson DW, Hawley CM
  Vascular Access Outcomes Reported in Maintenance Hemodialysis Trials: A Systematic Review. Am J Kidney Dis. 2018 Mar;71(3):382-391. doi: 10.1053/j.ajkd.2017.09.018. Epub 2017 Dec 6.
•   Villarreal MF, Siracuse JJ, Menard M, Assmann SF, Siami FS, Rosenfield K, Strong MB, Farber A
  Enrollment Obstacles in a Randomized Controlled Trial: A Performance Survey of Enrollment in BEST-CLI Sites. Ann Vasc Surg. 2020 Jan;62:406-411. doi: 10.1016/j.avsg.2019.08.069. Epub 2019 Sep 3.
•   Voorzaat BM, van der Bogt KEA, Janmaat CJ, van Schaik J, Dekker FW, Rotmans JI; Dutch Vascular Access Study Group
  Arteriovenous Fistula Maturation Failure in a Large Cohort of Hemodialysis Patients in the Netherlands. World J Surg. 2018 Jun;42(6):1895-1903. doi: 10.1007/s00268-017-4382-z.
•   Westfall PH, Tobias RD, Wolfinger RD
  Multiple comparisons and multiple tests using SAS: SAS Institute; 2011.
•   Wong V, Ward R, Taylor J, Selvakumar S, How TV, Bakran A
  Factors associated with early failure of arteriovenous fistulae for haemodialysis access. Eur J Vasc Endovasc Surg. 1996 Aug;12(2):207-13. doi: 10.1016/s1078-5884(96)80108-0.
•   Woo K, Pieters H
  The patient experience of hemodialysis vascular access decision-making. J Vasc Access. 2021 Nov;22(6):911-919. doi: 10.1177/1129729820968400. Epub 2020 Oct 29.
•   Woodside KJ, Bell S, Mukhopadhyay P, Repeck KJ, Robinson IT, Eckard AR, Dasmunshi S, Plattner BW, Pearson J, Schaubel DE, Pisoni RL, Saran R
  Arteriovenous Fistula Maturation in Prevalent Hemodialysis Patients in the United States: A National Study. Am J Kidney Dis. 2018 Jun;71(6):793-801. doi: 10.1053/j.ajkd.2017.11.020. Epub 2018 Feb 9. Erratum In: Am J Kidney Dis. 2018 Aug;72(2):314.
•   Yan Wee IJ, Yap HY, Tang TY, Chong TT
  A systematic review, meta-analysis, and meta-regression of the efficacy and safety of endovascular arteriovenous fistula creation. J Vasc Surg. 2020 Jan;71(1):309-317.e5. doi: 10.1016/j.jvs.2019.07.057. Epub 2019 Sep 26.

Randomized Controlled Trial Comparing endoAVF Versus surgAVF

Details for clinical trial NCT05654103