title: Clinical study protocol for the ARCH project - computational modeling for improvement of outcome after vascular access creation.
abstract: Despite clinical guidelines and the possibility of diagnostic vascular imaging, creation and maintenance of a vascular access (VA) remains problematic: avoiding short- and long-term VA dysfunction is challenging. Although prognostic factors for VA dysfunction have been identified in previous studies, their potential interplay at a systemic level is disregarded. Consideration of multiple prognostic patient specific factors and their complex interaction using dedicated computational modeling tools might improve outcome after VA creation by enabling a better selection of VA configuration. These computational modeling tools are developed and validated in the ARCH project: a joint initiative of four medical centers and three industrial partners (FP7-ICT-224390). This paper reports the rationale behind computational modeling and presents the clinical study protocol designed for calibrating and validating these modeling tools. The clinical study is based on the pre-operative collection of structural and functional data at a vascular level, as well as a VA functional evaluation during the follow-up period. The strategy adopted to perform the study and for data collection is also described here.
authors.affiliation: Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands. a.bode@mumc.nl
authors.forename: Aron
authors.initials: A
authors.lastname: Bode
authors.forename: Anna
authors.initials: A
authors.lastname: Caroli
authors.forename: Wouter
authors.initials: W
authors.lastname: Huberts
authors.forename: Nils
authors.initials: N
authors.lastname: Planken
authors.forename: Luca
authors.initials: L
authors.lastname: Antiga
authors.forename: Marielle
authors.initials: M
authors.lastname: Bosboom
authors.forename: Andrea
authors.initials: A
authors.lastname: Remuzzi
authors.forename: Jan
authors.initials: J
authors.lastname: Tordoir
mesh_terms: D015901:Angiography, Digital Subtraction; D001166:Arteriovenous Shunt, Surgical / Q000009:adverse effects; D003198:Computer Simulation; D005060:Europe; D006439:Hemodynamics; D006801:Humans; D007091:Image Processing, Computer-Assisted; D007676:Kidney Failure, Chronic / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D018810:Magnetic Resonance Angiography; D008955:Models, Cardiovascular; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012039:Regional Blood Flow; D006435:Renal Dialysis; D015203:Reproducibility of Results; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D014057:Tomography, X-Ray Computed; D018616:Ultrasonography, Doppler, Duplex; D034941:Upper Extremity / Q000098:blood supply*