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Arteriovenous Fistula clinical trials

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NCT ID: NCT05018962 Completed - Clinical trials for Dialysis Access Malfunction

Recurrent Stenoses in Arteriovenous Fistula (AVF) for Dialysis Access: CuttIng ballooN angioplaSTy Combined wITh Paclitaxel drUg coaTed Balloon Angioplasty, an observatIONal Clinical Study

INSTITUTION
Start date: September 8, 2017
Phase: Phase 2
Study type: Interventional

To determine if cutting balloon angioplasty combined with DEB angioplasty provides a higher primary patency after treatment of recurrent stenoses compared with cutting balloon angioplasty or angioplasty using DEB alone in the venous outflow AVFs. For cutting balloon angioplasty in venous stenosis, the primary patency after 12 months is 55-60% (9,16) and in recurrent stenoses up to 48%(10). We hypothesise that DEB angioplasty after cutting balloon angioplasty leads to improved primary patency at 12 months.

NCT ID: NCT04978155 Completed - Clinical trials for Arterio-venous Fistula

Usefulness of Doppler Ultrasound Carried Out by the Vascular Surgeon After Loco-regional Anesthesia for Preferred Access

Start date: January 1, 2020
Phase:
Study type: Observational

Preoperative vascular mapping with echo-Doppler is acknowledged as indispensable to create an arteriovenous fistula for haemodialysis (AVF). The conditions for performing this examination are not always ideal (venous vasospasm in cool temperatures, variability of the volume status in the dialysis patient). On the other hand, the use of a loco-regional anaesthesia (LRA) results in the vasodilation of the limb thus rendering it possible to use the veins which were initially considered too small. The aim of this study is to assess the functionality of our AVF when ultrasound identification was used by the surgeon after the LRA. These results have been compared with those of the preceding year during which this identification was not implemented.

NCT ID: NCT04925635 Completed - Nursing Caries Clinical Trials

Fistula Care and Mobile Health Applications in Hemodialysis Patients

Start date: June 1, 2020
Phase:
Study type: Observational

In recent years, applications designed specifically to encourage physical activity in the field of mobile technology have gained momentum. As a result of the literature research, no examples of mobile health applications developed with educational content on fistula care, which hemodialysis-dependent patients can reach at any time and place, have not been found. Based on this, it was planned to increase the knowledge level of arteriovenous fistula care and examine their self-care behaviors and their adaptation to the disease with the mobile application developed with a focus on education on fistula care, which can be used independently by machine-dependent hemodialysis patients. In this context, it is aimed that dialysis patients will benefit especially in arteriovenous fistula care applications, thanks to the ever-increasing mobile applications in daily use with the developing technology. It is thought that the use of these technology-based trainings will be more comfortable, useful and encouraging for their own self-care. It is planned to be a guide for healthcare professionals.

NCT ID: NCT04896476 Active, not recruiting - Kidney Diseases Clinical Trials

Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae

Start date: January 21, 2022
Phase: N/A
Study type: Interventional

Multi-center trial to assess the feasibility and safety of the EchoMark LP and the EchoMark diagnostic ultrasound system for assessing AV fistula blood flow, diameter, and depth.

NCT ID: NCT04796558 Active, not recruiting - Kidney Failure Clinical Trials

Validation of Arterio Venous Access Stage (AVAS) Classification

VAVASC
Start date: April 1, 2021
Phase:
Study type: Observational [Patient Registry]

VAVASC trial is an observational multicentre study. The aim of this trial is to validate AVAS (arteriovenous vascular access stage) classification. The classification is used for determining which type of access is the most suitable for the patient on the basis of the patient´s vascular anatomy The methodology of this trial is to apply AVAS classification on patients who are indicated for creation of vascular access for hemodialysis. Data on these patients (vascular anatomy status, AVAS type, and predicted type of arterio venous access, demographic data etc.) will be than statistically analysed. Patients will then undergo creation of the selected arteriovenous access. They will be observed in terms of the access functionality. The follow up will be 1 to 3 years. The second aim of this study is to evaluate the relationship between AVAS classification and uninterrupted use of the created arterio venous access.

NCT ID: NCT04795401 Active, not recruiting - Clinical trials for Arteriovenous Fistula

The Effectiveness of FRAME FR for AVF Repair in High-Flow Reduction & Stabilization, A Prospective Trial

FRAME
Start date: April 6, 2021
Phase: N/A
Study type: Interventional

Patients with end-stage renal disease require permanent vascular access to enable safe and effective hemodialysis. An arteriovenous fistula (AVF), where a vein is mobilized and connected to an artery in the arm, is considered the gold standard and first choice for vascular access. After fistula creation, the vein is subjected to high pressure and flow, and undergoes remodeling. This includes the possibility of significant dilatation and intimal hyperplasia. Normal AVF flow required for effective dialysis is around 0.6 liters/min or 0.4-0.8 liters/min. However, in at least 20% of patients, excessive remodeling and dilatation of the fistula result in a high flow AVF with >2 liters/min. High flow fistulas significantly increase the risk for the development of high output cardiac failure, skin breakdown, bleeding, hand ischemia, and other systemic complications. In cases of high flow AVF, venous reconstruction procedures, banding and/or plication, are often required to limit venous diameter and flow. The longevity of this procedure is limited as the reconstructed segment remodels and re-dilates due to ongoing arterial pressure. Banding and plication are both procedures that are designed to increase resistance to flow. Banding is performed by wrapping a segment of polytetrafluoroethylene (PTFE) around the outflow tract of the fistula, or by placing a suture around the fistula near the arterial anastomotic area to create a narrowing. Fistula plication involves narrowing of a short segment of the proximal venous outflow tract, usually accomplished by suturing or stapling the fistula for 2-6 cm. One of the notable systemic effects of a hemodialysis AVF is an acute decrease in systemic vascular resistance with a simultaneous increase in venous return to the heart, and thus an increase of the cardiac output. Cardiac failure occurs more frequently in patients with an access flow QA>2 l/min and CPR≥20%. Another adverse systemic effect of AV fistulas is pulmonary hypertension. The increased flow volume to the heart from an AV fistula yields an increase in pulmonary pressures. This can limit pulmonary vasodilation and result in pulmonary hypertension.

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.

NCT ID: NCT04720079 Completed - Clinical trials for Regional Anesthesia Success

Paravertebral Block With Brachial Plexus Block for Upper Arm Arteriovenous Fistula Surgery

Start date: November 15, 2020
Phase: N/A
Study type: Interventional

The primary goal of this quality improvement project is to find the optimal surgical conditions for patients undergoing upper arm arteriovenous graft surgery. Currently, there are two anesthetic techniques used in clinical practice. The goal is to standardize future practice and improve the care of patients postoperatively. The two techniques used in conjunction with a brachial plexus block are paravertebral nerve block and subcutaneous infiltration.

NCT ID: NCT04698512 Completed - Clinical trials for End Stage Renal Disease

MAgicTouch™ Intervention Leap for Dialysis Access (MATILDA) Trial

MATILDA
Start date: May 21, 2019
Phase:
Study type: Observational [Patient Registry]

For patients with End Stage Renal Failure (ESRF), the surgical creation of an Autogenous Arteriovenous Fistula (AVF) or Autogenous Arteriovenous Graft (AVG) is the recognised standard for providing vascular access. A functioning dialysis vascular access is essential to facilitate hemodialysis (HD) treatment. Advantages include improved hemodialysis initiation time, improved dialysis quality, better maintenance of accesses and generally, better outcomes in patients. Unfortunately almost 50% of AVF and AVG fail after a median lifetime of 3 to 7 years and 12 to 18 months respectively. Vascular access dysfunction is a major cause of morbidity and hospitalisation for ESRF patients, costing the healthcare system USD 18 million globally. Venous stenosis and scarring are caused by trauma from surgical access creation when the circuit comes arterialized and from repeated percutaneous punctures from subsequent hemodialysis. This study is performed to evaluate Sirolimus-coated balloon efficacy and safety using MagicTouch™ Drug coated balloon catheter (Concept Medical Inc, Tampa, FL, US) on AVF patency with de novo and recurrent stenosis.

NCT ID: NCT04634916 Recruiting - Clinical trials for End-stage Renal Disease

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

CONNECT-AV
Start date: March 26, 2021
Phase: N/A
Study type: Interventional

A prospective, single-arm, multi-center post-market surveillance study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis.