Active clinical trials for "Arteriovenous Fistula"

To evaluate the safety and efficacy of the Zylox Drug Coated Balloon (DCB) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity in China.

The purpose of this research study is to determine whether two different types of forearm exercise, performed before fistula creation surgery, can improve surgery success and fistula maturation.

The purpose of the study is to investigate the efficacy of the ROX coupler in treating patients with tilt test proven Neurally mediated syncope.

Hemodialysis (HD) vascular access dysfunction is a huge clinical problem which results in significant clinical morbidity in patients with End Stage Renal Disease (ESRD), causing a severe economic burden on any health care system. Arteriovenous (A-V) dialysis accesses are the preferred form of permanent dialysis access as compared to central venous catheters (CVC) . One of the reasons for CVC use is poor long term patency rates of A-V access. Arteriovenous Grafts (AVG) have a primary patency rates of just under 50% at 12 months and around 33% at 18 months. Native arteriovenous fistula (AVF) are slightly better with primary patency rates of around 60 percent at one year and 51 percent at 2 years. The most common cause for AVF and AVG dysfunction is stenosis development due to neointimal hyperplasia (NIH) within the circuit leading to access thrombosis. Percutaneous transluminal angioplasty (PTA) is the current standard of treatment for these lesions. Despite being the treatment of choice for these lesions patency rates after PTA continue to be dismal. One of the problems with poor long term outcomes after successful intervention is how you assess immediate intervention success. Successful angioplasty is defined by Dialysis Outcome Quality Initiative (DOQI) guidelines as one where only less than 30% residual stenosis remains at the end of intervention. Unfortunately angiographic images post angioplasty correlate poorly with improvement of access flows through the arteriovenous circuit. There are two main problems with these practice standards. First, they are based on a 2-dimensional angiographic view of the lesion which may be misleading. Secondly, this assessment of recoil is very subjective and not base on objective data. Access flow monitoring can now be performed intra-procedurally with thermal dilution technique. Its benefit was shown in a small pilot study. To date there have not been any randomized controlled trials to assess the benefit of such an approach where intervention is based on improvements in access flow at the time of intervention. We hypothesize that such an approach will improve outcomes after interventions related to access dysfunction. This may also identify the right scenarios in which stent placement may benefit thus improving outcomes after stent placement as well.

Primary failure is the most common complication of newly created arteriovenous fistulas (AVFs) and an important contributor to end stage renal disease (ESRD) patients' morbidity and mortality. Recently, the investigators have found that high intensity atorvastatin (40 mg/day) reduces AVF primary failure significantly when compared to other statins or no statin treatment in three separate prospective and retrospective studies done in collaboration with the University of Miami. Based on these findings and considering the necessity for a therapy to improve AVF maturation rates, the investigators propose the realization of a feasibility pilot double blinded randomized controlled trial (RCT). In this study, a total of 50 patients will be randomly allocated to receive high intensity atorvastatin (40 mg daily) or placebo starting at two weeks before surgery and until the end of the observational period (6 weeks after surgery). Present trial will reveal crucial feasibility information such as the appropriateness of the eligibility criteria, patient recruitment and retention rates, compliance, adverse events, efficacy of patient follow-ups, and readiness of the facilities and involved personnel; while having as a secondary endpoint the predictive measurements of diameter and AVF blood flow 6 weeks after fistula creation useful for the estimation of the probable effect of proposed intervention. Here, the investigators aim to pave the way for a future multicenter Phase II RCT seeking to prove the efficacy of atorvastatin therapy as a perioperative intervention to reduce AVF primary failure.

There is no randomized control study to determine if the beneficial effects of beraprost sodium could improve the patency of arteriovenous fistula in hemodialysis patients. Therefore, this study is aimed to demonstrate the use of beraprost sodium can improve the patency of arteriovenous fistula in patients undergoing hemodialysis. This study is prospectively randomize controlled open-label trials in patients who newly made artificial arteriovenous fistula for hemodialysis. This study is a pilot study, and the target number of subjects is 60 in total, 30 in the treatment group and 30 in the control group. After randomization, the treatment group takes a beraprost sodium for 6 months and the control group does not take placebo. Treatment lasts for 6 months after dosing but continues until the patient changes the renal-replacement therapy method or falls under the exclusion criteria. The patient should visit at 1, 3, and 6 months after arteriovenous graft surgery to check the access site after graft surgery. The doppler ultrasound test is performed to measure the access blood flow rate and patency of arteriovenous fistula.

To investigate the effect of pre-operative exercise on Hemodynamics in the fistula artery and vein, pre and post AV fistula formation Suitability of cannulation of AV fistula at 8weeks

The purpose of this randomised clinical trial is to evaluate the efficacy of drug-eluting balloon compared to conventional balloon in balloon-assisted maturation of non-maturing arteriovenous fistula in adult renal failure patients.

The narrowing of Dialysis Fistulae or Grafts is a near universal problem in patients with end-stage renal disease (ESRD) and requires patients to undergo repeated angioplasty or mechanical opening of the fistula.

This is a pilot study investigating a new concept of intra-procedural percutaneous duplex ultrasound (DUS) volume flow-guided balloon angioplasty for the quantification and optimization of endovascular treatment outcomes of dysfunctional autologous arteriovenous fistulae (AVF).