Clinical Trials Logo

Clinical Trial Summary

The surgical formation of an AVF offers a unique example of vascular remodelling and adaption. Yet, the specific factors which elicit remodelling events which determine successful maturation or failure have not been unambiguously determined. Computational fluid dynamic (CFD) simulations are increasingly been employed to investigate the interaction between local haemodynamics and remodelling and can potentially be used to assist in clinical risk assessment of maturation or failure. However, these simulations are inextricably linked to their prescribed boundary conditions and are reliant on in vivo measurements of flow and pressure to ensure their validity. This study will compare in vivo measurements of the pressure distribution across an AVF against a representative numerical model.


Clinical Trial Description

Most patients with End Stage Renal Disease (ESRD) will require haemodialysis. Several studies have recognized a well-functioning Arterio-Venous Fistula (AVF) as the best modality for access in patients with ESRD undergoing haemodialysis. A mature AVF has lower incidence of thrombosis and stenosis compared to the other two available modalities of the Arterio-Venous Graft (AVG) and Central Venous Catheter (CVC). This translates into prolonged patency rates and lower risk of infection. The use of AVF's are also associated with lower mortality, and costs. However, significant numbers of AVFs [20% to 60 %] are known to fail to mature into functioning fistulas. Issues such as impaired vein remodelling, intimal hyperplasia, technical problems, unrecognized stenosis within the outflow vein, inflow problems, or steal syndromes can all lead to failure of achieving a mature AVF. The aim of the study is to examine the relationship between the pressure gradient within the surgically formed AVF and its' maturation and functioning status. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04293614
Study type Observational
Source University Hospital of Limerick
Contact
Status Completed
Phase
Start date August 14, 2019
Completion date January 14, 2023

See also
  Status Clinical Trial Phase
Completed NCT03246984 - VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ N/A
Withdrawn NCT03538392 - Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
Completed NCT03044496 - NIRS Measurement After SCP Block
Recruiting NCT03054623 - Hemodynamic Assessment of Distal Revascularization Interval Ligation N/A
Completed NCT05801549 - Arterio-Venous Fistula Audit. Successful Utilisation Rates of Arterio-Venous Fistulae for Haemodialysis at University Hospital Limerick
Completed NCT04011072 - Far Infrared Therapy on Arteriovenous Fistulas in Hemodialysis Patients N/A
Completed NCT03242343 - VasQ External Support for Arteriovenous Fistula N/A
Not yet recruiting NCT06336226 - Brachio Basilic Arterio Venous Fistula One Stage vs Two Stage N/A
Recruiting NCT06091839 - Anchor Versus Parachute Suturing Technique in Arteriovenous Fistula Creation for Hemodialysis N/A
Enrolling by invitation NCT04381754 - Use of Implanting the Biotronik Passeo-18 Lux Drug Coated Balloon to Treat Failing Haemodialysis Arteriovenous Fistulas and Grafts.
Enrolling by invitation NCT04054440 - Outpatient Office Based Endovascular Procedures
Completed NCT03988270 - Prefistula Forearm Exercise in Pts Requiring Chronic HD Therapy N/A
Completed NCT04925635 - Fistula Care and Mobile Health Applications in Hemodialysis Patients
Completed NCT04177901 - The Use of NIRS in Brachial Plexus Block N/A
Completed NCT04978155 - Usefulness of Doppler Ultrasound Carried Out by the Vascular Surgeon After Loco-regional Anesthesia for Preferred Access
Completed NCT04222881 - End-to-side Versus Side-to-side Anastomosis With Distal Vein Ligation for Arteriovenous Fistula Creation
Recruiting NCT03853070 - Post Market Clinical Follow-Up for ED Coil / Electro-detach Generator v4
Recruiting NCT03731000 - PHIL® Embolic System Pediatric IDE N/A