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Hemodialysis Access Failure clinical trials

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NCT ID: NCT06034691 Recruiting - Clinical trials for Hemodialysis Access Failure

Exploratory Research of PCSK9 Inhibitor on Patency of aAVF After PTA With PCB

Start date: September 10, 2023
Phase: N/A
Study type: Interventional

Autologous arteriovenous fistula (AVF) is the preferred vascular pathway type for maintenance hemodialysis (MHD) patients. The K/DOQI guidelines suggest that the use of percutaneous transluminal angioplasty (PTA) as the primary treatment for AVF stenosis is reasonable. However, the durability of PTA is limited. In order to reduce the risk of dysfunction recurrence after the intervention, there have been reports in recent years that drug-coated balloons (DCB) are used in the treatment of vascular stenosis in hemodialysis. Multiple factors have limited the efficacy of DCB. Previous studies on the related factors of hemodialysis access stenosis showed that Dyslipidemia was significantly related to the short initial patency rate, and Dyslipidemia was an important predictor of secondary patency loss. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are a new type of lipid-lowering drug that can prevent vascular calcification. Previous studies have shown that PCSK9 inhibitors have good lipid-lowering effects in both MHD patients and nondialysis patients, and the use of PSK9 inhibitors at the same dose as nondialysis patients is safe in MHD patients. There are currently few studies on the use of paclitaxel-releasing balloon dilation combined with PCSK9 inhibitors to improve autologous internal fistula. Therefore, the investigators applied a prospective, randomized, and controlled study method to preliminarily explore the effect of paclitaxel releasing balloon combined with PCSK9 inhibitor on improving the postoperative patency rate of AVF and the safety of the combined application.

NCT ID: NCT06001827 Recruiting - Clinical trials for Chronic Kidney Diseases

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

SAVE-FistulaS
Start date: November 20, 2023
Phase: N/A
Study type: Interventional

This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap.

NCT ID: NCT05911451 Recruiting - Clinical trials for Arteriovenous Fistula

Optimizing Access Surgery In Senior Hemodialysis Patients

OASIS
Start date: December 1, 2019
Phase: N/A
Study type: Interventional

The number of elderly hemodialysis patients is growing. Vascular access complications are a major determinant of the quality of life and health care costs for these vulnerable patients. The three different types of vascular access, i.e. autologous arteriovenous fistulas, arteriovenous grafts, and central venous catheters, have never been compared in randomized controlled trials. This project will deliver the much-needed evidence to determine the optimal strategy for vascular access creation in elderly hemodialysis patients in order to deliver better health care at lower costs.

NCT ID: NCT05906550 Recruiting - Clinical trials for Hemodialysis Access Failure

Flow Dysfunction of Hemodialysis Vascular Access

FLOW
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

The FLOW trial evaluates the follow-up of the vascular access for hemodialysis. In current clinical care, vascular access flow volume is periodically assessed to detect and treat asymptomatic stenosis. The FLOW trial will determine whether it is safe to abandon this practice of active surveillance. Vascular access stenosis will then be treated only when clinical problems of flow dysfunction occur during hemodialysis. The investigators expect that the intervention rate and medical costs will be reduced by 40% when correction of vascular access stenosis is triggered by clinically apparent access dysfunction rather than asymptomatic flow reduction.

NCT ID: NCT05612022 Recruiting - Clinical trials for End Stage Renal Disease

Acoustic Analysis of VA Sounds

VAsound
Start date: February 15, 2023
Phase:
Study type: Observational

End-stage renal disease (ESRD) is a growing global health problem, strictly connected with progressive ageing population and longer survival of patients living on renal replacement therapy. The majority of ESRD patients is on hemodialysis (HD) treatment. A successful HD procedure requires a functioning vascular access (VA) to provide safe and long-lasting way to connect patient circulation to the artificial kidney. The current recommendation for VA is the native arteriovenous fistula (AVF), surgically created in the forearm by an anastomosis between a vein and an artery. The AVF, despite being the first-choice treatment, is still affected by high non-maturation and early failure rates, requiring in most of the cases, the creation of a new VA. An arteriovenous graft (AVG) is the second choice for a VA. Surgery is done using an artificial plastic tube that connects an artery to a vein. The AVG matures earlier than AVF (2/3 vs 6 weeks), but it is more prone to infections and has lower survival. It would be important to identify patients at risk of VA failure, but there is currently a lack of adequate strategies for surveillance. A continuous monitoring of the VA function would help in identification of reduced blood flow and VA stenosis, that could be treated by interventional radiologists before AVF or AVG complete closure. Over the years, nurses and nephrologists got used to touch the VA and qualitatively evaluate its vibration, named "thrill", and the sounds emitted by the same using their stethoscope. The purpose of this study is to assess the feasibility of VA sound recording and analysis and provide preliminary evidence of VA sound clinical validity and utility to assess, monitor and predict vascular remodelling occurring in AVFs and AVGs. This is a single center prospective observational study involving the acquisition of VA sounds and Doppler US examinations in consenting patients with ESRD. To reach this goal, two groups of ESRD patients in need of VA surgery to perform HD treatment will be involved: Group 1. Patients with AVF as first line HD access option. Group 2. Patients with AVG as first line HD access option.

NCT ID: NCT05418816 Active, not recruiting - Clinical trials for Chronic Kidney Diseases

SelfWrap-Assisted Arteriovenous Fistulas

SW-AVF
Start date: June 14, 2021
Phase: N/A
Study type: Interventional

This is a single-center, prospective, single-arm clinical study to evaluate the feasibility, safety, and performance of VenoStent's SelfWrap® Bioabsorbable Perivascular Wrap on arteriovenous fistulas (AVFs). All participants are chronic kidney disease (CKD) patients already receiving hemodialysis treatments that are referred for creation of a new arteriovenous fistula (AVF).

NCT ID: NCT05228132 Terminated - Clinical trials for End Stage Renal Disease

The Pristine Post-Market Study

Start date: May 16, 2022
Phase: N/A
Study type: Interventional

This is a prospective, multi-center, single-arm study designed to assess the safety and performance of the Pristineā„¢ Long-Term Hemodialysis Catheter.

NCT ID: NCT05096416 Not yet recruiting - Clinical trials for Hemodialysis Access Failure

Three-dimensional (3D) Printed Hemodialysis Vascular Model

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Infiltration of a surgically-placed hemodialysis vascular access (HVA) is recognized as a major contributor to the high hospital re-admission rate in dialysis-dependent patients. Three dimensional modeling has been demonstrated as a critical tool for procedurists in preparation for surgical interventions but no such modeling is yet available for dialysis specialists to avoid the common complication of HVA infiltration. Contrast enhanced magnetic resonance angiography (MRA) can be used to generate a three dimensional image data that could render a three dimensional resin-based model of a vascular access.

NCT ID: NCT05081648 Completed - Clinical trials for Chronic Kidney Diseases

Must Cannulation Technique of Vascular Access in Patients Undergoing Haemodialysis: Contributions for a Safe Nursing Intervention

MuST
Start date: January 3, 2022
Phase: N/A
Study type: Interventional

The aims of this study are to: - Determine the AVF (arteriovenous fistula) survival of patients submitted to MuST compared to those submitted to RL (rope-ladder). - Determine the AVF (arteriovenous fistula) complication rate of patients submitted to MuST compared to those submitted to RL (rope-ladder). - Analyze the intensity of pain perceived by the patient with each cannulation technique under study.

NCT ID: NCT04736875 Completed - Clinical trials for End-stage Renal Disease

Arteriovenous Fistula Maturation Evaluation Study. FAME Study

Start date: February 1, 2019
Phase:
Study type: Observational

Study of the features of hemodynamic and clinical maturation of the native arteriovenous fistula for hemodialysis.