Clinical trials: Hemodialysis Access
End Stage Renal Disease, Hemodialysis Access Failure
PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis
The goal of this observational study is to increase the understanding of the safety and performance of Merit Medical's HeRO Graft System (HeRO) and Super HeRO Adaptor and Support Seal System (Super HeRO) devices.
- Trial name
- PReSeRVE-HD (NCT06422871)
- Testing
- HeRO® Graft System or Super HeRO® System
- Where
- 7 sites in United States
- Volunteers
- 100 people
- Sponsor
- Merit Medical Systems, Inc.
Arteriovenous Fistula
Correlation Between Access Blood Flow and Extracorporeal Blood Flow
The purpose of this study is to determine if Effective Extracorporeal Blood Flow(eEBF) has correlation with Access Blood Flow (Qa), when eEBF adjusts with Dynamic Arterial Line Pressure (DALP) in patients with Arteriovenous…
- Trial name
- NCT00522704
- Testing
- Dynamic Arterial line Pressure (DALP)
- Where
- Mexico
- Volunteers
- 30 people
- Sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
Kidney Failure, Chronic, Renal Dialysis
Evaluating the Safety and Effectiveness of the InnAVasc Graft for Dialysis Access in Patients With Kidney Failure
The CSP-1001 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for hemodialysis in participants suffering from end stage renal failure (ESRD).
- Trial name
- NCT03645681
- Testing
- InnAVasc arteriovenous graft surgical implant
- Where
- 7 sites in United States
- Volunteers
- 26 people
- Sponsor
- W.L.Gore & Associates
End Stage Renal Failure on Dialysis, Hyperplasia
Safety Study of the Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access
The purpose of this study is to determine whether the long term use of the experimental Vascular Wrap(TM) Paclitaxel-Eluting Mesh is safe in the treatment of subjects needing hemodialysis access (via an expanded…
- Trial name
- NCT01033357
- Testing
- Graft, Vascular Wrap, Lifespan® ePTFE Vascular Graft Only
- Where
- 30 sites in United States
- Volunteers
- 222 people
- Sponsor
- Angiotech Pharmaceuticals
End-stage Renal Disease
Xeltis Hemodialysis Access Graft: aXess Pivotal Study
A prospective, single arm, non-randomized pivotal study to evaluate the safety and performance of the Xeltis hemodialysis access graft in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis…
- Trial name
- NCT05473299
- Testing
- Xeltis Hemodialysis Access (aXess) graft
- Where
- 22 sites in Belgium, Germany and 7 more
- Volunteers
- 120 people
- Sponsor
- Xeltis
Hemodialysis Access Failure
Collateral Ligation in Failing Fistulas
Arteriovenous fistulas (AVFs) for hemodialysis often fail to become usable due to failure to mature (FTM). The most common cause is narrowing of the artery or vein (stenosis).
- Trial name
- CLiFF (NCT03365089)
- Testing
- Collateral vein ligation
- Where
- United States
- Sponsor
- Massachusetts General Hospital
Arteriovenous Fistula Stenosis, Arteriovenous Fistula
A Prospective, Multi-center Study to Evaluate Efficacy and Safety of BSJ020R in Treatment of AVF for Hemodialysis (RANGER AV Japan Study)
A prospective, multi-center study to evaluate efficacy and safety of BSJ020R in treatment of AVF for hemodialysis
- Conditions
- Arteriovenous Fistula Stenosis, Arteriovenous Fistula, Vascular Access
- Trial name
- NCT06639451
- Testing
- RANGER™ Paclitaxel Coated Balloon Catheter
- Where
- 8 sites in Japan
- Volunteers
- 186 people
- Sponsor
- Boston Scientific Corporation
Kidney Failure, Acute, Kidney Failure, Chronic
Ultrasound for Guidewire Detection
The aim of the project is to check if there is a possibility for a nephrologist to visualise the guidewire by means of available ultrasound scanners.
- Trial name
- NCT03727581
- Testing
- Ultrasound guidance
- Where
- Poland
- Volunteers
- 30 people
- Sponsor
- Wroclaw Medical University
Arterio-venous Fistula
Brachio Basilic Arterio Venous Fistula One Stage vs Two Stage
The aim of this work was to compare primary failure rates and the primary functional patency of one-stage vs two stage brachiobasilic fistulas to compare the two surgical techniques .
- Trial name
- NCT06336226
- Testing
- Brachio basilic arterio venous fistula one stage versus two stage
- Volunteers
- 50 people
- Sponsor
- Assiut University
End Stage Kidney Disease, Chronic Kidney Diseases
The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Post-Market Investigation
This is a global, multi-center, prospective, post-market, confirmatory, interventional, non-randomized, single-arm clinical investigation evaluating arteriovenous fistula (AVF) creation by means of the WavelinQ™ EndoAVF System in…
- Conditions
- End Stage Kidney Disease, Chronic Kidney Diseases, Kidney Failure, Kidney Insufficiency
- Trial name
- WAVE-Global (NCT04626427)
- Testing
- WavelinQ™ EndoAVF System
- Where
- 3 sites in Belgium, Greece and 1 more
- Volunteers
- 21 people
- Sponsor
- C. R. Bard
Hemodialysis Access Failure, Blood Pressure
BP Variability on the Outcomes of Hemodialysis Vascular Access
Hemodialysis vascular access dysfunction continues to be a major source of morbidity and mortality in patients with ESRD. Thrombosis is the most common cause of secondary vascular access failure Although intimal hyperplasia at…
- Conditions
- Hemodialysis Access Failure, Blood Pressure, Dialysis Access Malfunction
- Trial name
- NCT04692636
- Testing
- Measure: BP measurements, inter-dialysis BP variability, intra-dialysis hypotension
- Where
- Taiwan
- Volunteers
- 1,300 people
- Sponsor
- National Taiwan University Hospital Hsin-Chu Branch
Hemodialysis Catheter Complication, Catheter Thrombosis
Hemodialysis Catheter Complications in the Emergency Department Versus Hemodialysis Unit
This prospective observational cohort study was designed to compare the risk of catheter thrombosis and catheter-related infection between adult patients who underwent temporary hemodialysis catheter insertion in the emergency…
- Conditions
- Hemodialysis Catheter Complication, Catheter Thrombosis, Catheter-Related Infections, Hemodialysis Vascular Access
- Trial name
- NCT07645365
- Where
- Turkey (Türkiye)
- Volunteers
- 398 people
- Sponsor
- Antalya Health Sciences University
Kidney Failure, Chronic, Arteriovenous Fistulae
Preoperative Arteriovenous Fistula Simulation Study (ShuntSimulationStudy)
Patients suffering from end-stage renal disease (ESRD) are dependent on renal replacement therapy (dialysis). The majority of dialysis is facilitated by hemodialysis.
- Trial name
- 3S (NCT02453412)
- Testing
- AVF-simulation
- Where
- 9 sites in Netherlands
- Volunteers
- 236 people
- Sponsor
- Maastricht University Medical Center
End Stage Renal Disease (ESRD)
Multi-Site STARgraft (10401) Trial
This is a multi-site, single-blind with parallel group, randomized controlled trial of Healionics STARgraft (10401) vascular graft for hemodialysis access compared with a market-leading commercially available ePTFE vascular graft…
- Trial name
- NCT07557862
- Testing
- STARgraft (10401), Gore Propaten
- Where
- 7 sites in Brazil, Colombia
- Volunteers
- 111 people
- Sponsor
- Healionics Corporation
Pulmonary Hypertension (PH), End Stage Kidney Disease (ESRD)
Euvolemia-Based Assessment of Pulmonary Hypertension in Stable Hemodialysis Patients
Pulmonary hypertension (PH) is a frequent and clinically significant complication in patients with end-stage kidney disease (ESKD) undergoing maintenance hemodialysis (HD).
- Conditions
- Pulmonary Hypertension (PH), End Stage Kidney Disease (ESRD), Hemodialysis Patients, Volume Overload
- Trial name
- EU-PHASE-HD (NCT07676786)
- Testing
- Observational Assessment
- Where
- 2 sites in Romania
- Volunteers
- 30 people
- Sponsor
- Stefan Lujinschi
Chronic Kidney Disease Requiring Hemodialysis, End Stage Renal Disease (ESRD)
Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System for Creating Hemodialysis Vascular Access
The Velocity Percutaneous Arterio-Venous System is a minimally invasive method of creating hemodialysis vascular access. The study aims to understand clinical efficacy and initial clinical safety data of the device.
- Trial name
- VENOS-2 (NCT06712251)
- Testing
- Velocity pAVF System
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Venova Medical
Chronic Kidney Disease
A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients
PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel.
- Trial name
- NCT00679991
- Testing
- PRT-201
- Where
- 11 sites in United States
- Volunteers
- 66 people
- Sponsor
- Proteon Therapeutics
Renal Failure, End Stage Renal Disease
Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access.
- Conditions
- Renal Failure, End Stage Renal Disease, Hemodialysis, Vascular Access
- Trial name
- NCT02644941
- Testing
- Human Acellular Vessel (HAV), ePTFE graft
- Where
- 38 sites in United States, Germany and 4 more
- Volunteers
- 355 people
- Sponsor
- Humacyte, Inc.
Native Arteriovenous Fistula, Stenosis
Drug Eluting Balloon Venoplasty in AV Fistula Stenosis
DeVA is a single blinded, prospective, multicentre RCT designed to determine the safety and effectiveness of a drug eluting angioplasty balloon compared with a standard angioplasty balloon in patients with symptomatic native AV…
- Trial name
- DeVA (NCT02902094)
- Testing
- Drug eluting balloons, Non drug eluting balloons
- Where
- United Kingdom
- Volunteers
- 186 people
- Sponsor
- University Hospital Birmingham
End Stage Renal Disease
Evaluation of STARgraft-3 for Hemodialysis
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-3 hemodialysis access graft.
- Trial name
- NCT05729620
- Testing
- Implant of STARgraft-3 shunt in the upper arm and subsequent use for hemodialysis access
- Where
- Paraguay
- Volunteers
- 21 people
- Sponsor
- Healionics Corporation