Active clinical trials for "Arteriovenous Fistula"

The primary objective of this double-blind study is to compare the frequency of primary patency at 6 months in patients with stenosis of arteriovenous fistula (AVF) treated either by conventional angioplasty + angioplasty with balloon impregnated with paclitaxel or by conventional angioplasty + angioplasty with placebo balloon (balloon not impregnated with paclitaxel). The other objectives of the study are: To compare the frequency of primary patency at 3 months and 12 months. To compare the rate of restenosis > 50% at the site of angioplasty at 3, 6 and 12 months. To compare, at 3, 6 and 12 months, the proportion of patients with arteriovenous fistula deteriorating back to preoperative flow rate (within 20% of preoperative flow rate). To compare, at 3, 6 and 12 months, the proportion of AVF with a flow rate < 500 ml / min. To compare, at 3, 6 and 12 months, the cumulative rate of thrombosis. To compare, at 3, 6 and 12 months, the medical costs related to direct medical care, initial treatments, monitoring, diagnosis and treatments of complications.

This is a pilot, single-center, randomized trial of 90 subjects to evaluate complication rates and functional status decline in subjects age 65 years and older referred for vascular access placement. Subjects will be randomized to arteriovenous fistula (AVF) (n = 45) versus arteriovenous graft (AVG) (n = 45), placed in a vascular access monitoring protocol, and undergo measurements of functional status including gait speed, grip strength, and self-reported function over 6 months. The primary hypothesis to be tested is that AVF placement will result in a higher proportion of primary access failure as defined by a binary composite primary endpoint of an unsalvageable access or an immature access or a non-functional access measured at 6 months compared to AVG placement. In addition, the study will evaluate whether AVF placement and a greater number of access procedures will result in a greater decline in functional status as measured by the average change over 6 months in gait speed, grip strength, and self-reported function as assessed by the Disabilities in Arm, Shoulder and Hand Survey.

This is a prospective single arm study enrolling patients who are scheduled for creation of a new Brachiocephalic or Radiocephalic AV fistula. Up to 80 patients will be enrolled, 50 with upper arm AV fistula and 30 with forearm AV fistula. All patients will be implanted with the VasQ device, a subcutaneous arteriovenous conduit support for vascular access. The follow up period in this study will be for a duration of 12 months, with follow up visits scheduled at 1, 3, 6, 9, and 12 months.

The Objectives of this study are: To determine if vorapaxar safely improves arteriovenous (AV) fistula functional maturation when administered during the maturation process compared with placebo. To determine if vorapaxar safely improves AV fistula patency, allowing for secondary procedures to aid in fistula maturation compared with placebo. To determine if vorapaxar safely facilitates successful cannulation of AV fistulas for hemodialysis compared with placebo. This is a randomized placebo-controlled double-blind pilot trial. Study procedures will be conducted at Stanford University Medical Center, and standard-of-care (SOC) procedures will be conducted at Stanford and it's affiliated hospitals (Veteran's Affairs Palo Alto Health Care System and the Stanford Vascular Surgery Clinic at Valley Medical Center). The investigators expect to enroll 128 patients. Patients will be assigned to treatment groups with a 1:1 randomization in blocks of 4 at the conclusion of the AV fistula creation. Patients will be stratified based on fistula location (lower arm versus upper arm).

Arteriovenous fistula is the preferred access for hemodialysis, and cannulation using a "button-hole" technique is increasingly recommended. By using the same two sites for cannulation there are reports of less risk of complications and less pain for the patient. However, button-hole cannulation can be difficult for the dialysis nurse, and failing cannulations can damage the AV fistula and increase patient discomfort. The investigators therefore will test whether a simple marking on the skin of the direction and angle of cannulation used in each specific patient could improve the probability of a successful and painfree cannulation.

This project will examine if enhancing Nitric Oxide (NO) bioavailability increases the rates of arteriovenous fistula (AVF) maturation in end stage renal disease patients requiring vascular access for hemodialysis. To enhance NO bioavailability the study team will utilize a program of forearm exercise training, application of nitroglycerin ointment or both. Goals of this study are (A) to measure if recruited subjects can tolerate the intervention protocols, and determine if dependent variable measures, including surgery outcome, and measurement of physiologic and biologic markers, can be obtained; (B) To measure subject compliance and adherence rates for each of the intervention arms and testing visits; (C) To examine which intervention or combination of interventions demonstrates the strongest preliminary effects in order to estimate power for a pivotal intent to treat trial; and (D) explore group differences in clinical vascular markers and biologic markers in vein tissue.

This study is aimed to assess the value of three-dimensional time-of-flight magnetic resonance angiography (3D-TOF-MRA) in hemodialysis patients with occlusive disease in arteriovenous fistula (AVF). All participants will receive 3D-TOF-MRA and ultrasound to detect the stenosis degree of AVF.

A patient with an arteriovenous fistula (AVF) receiving chronic hemodialysis (HD) treatment is cannulated 312 times a year on average. The patients cannot comply with dialysis treatment and the quality of life is decreased by pain when the fistula cannot be accessed with a single attempt. Sharp pain depends on the tear in the skin, the tissue where the sensitive nerve ends receptive to pain are located, and it is particularly important during AVF puncture. Also, punctures are accompanied by haemorrhages and frequent loss of blood.

All vascular access guidelines recommend monitoring and surveillance protocols to prevent vascular access complications in hemodialysis units. However, in the case of second generation screening techniques which determine access blood flow measurement (QA), there is a huge controversy about it´s efficiency. Although multiple observational studies find a decrease in the thrombosis rate and an increased primary assisted patency survival related to the use of these techniques, a recently published meta-analysis find contradictory results in the randomized controlled trials, affirming that the measurement of QA is useless in grafts and questionable in native arteriovenous fistulae (AVF). We have designed a multicenter, prospective, open label, controlled, randomized trial, to prove the usefulness of the QA measurement using two complementary second generation techniques, Doppler ultrasound and Transonic dilution method, compared to the classical monitoring and surveillance methods. The primary endpoint will be a reduction in the thrombosis rate with an increased assisted primary patency survival, and a cost effectiveness economic analysis. As secondary endpoints we will analyze the impact over non-assisted primary patency survival and secondary patency survival.

The purpose of this study is to evaluate the Lutonix® 035 Drug Coated Balloon PTA Catheter (CE mark) for use as intended in the treatment of subjects with clinically significant hemodialysis vascular access stenosis or occlusion.