Clinical trials: AV Fistula
Chronic Kidney Disease
Novel Endovascular Access Trial (NEAT)
The objective of this study is to evaluate the safety and efficacy of the FLEX System when used to create an arteriovenous fistula (AVF or AV fistula) percutaneously in patients with Chronic Kidney Disease (CKD) who require…
- Trial name
- NEAT (NCT02036671)
- Testing
- The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access
- Where
- 9 sites in Australia, Canada and 1 more
- Volunteers
- 80 people
- Sponsor
- C. R. Bard
End Stage Renal Disease, AV Fistula
Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae
The SAVE Study will evaluate the safety and efficacy of the Venous Window Needle Guide in achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis as prescribed.
- Conditions
- End Stage Renal Disease, AV Fistula, Kidney Failure
- Trial name
- SAVE (NCT01471041)
- Testing
- Venous Window Needle Guide
- Where
- 2 sites in United States
- Volunteers
- 54 people
- Sponsor
- Vital Access Corp.
Chronic Kidney Disease, Hemodialysis Access
Pivotal Study of the Velocity™ pAVF System
This study will evaluate the Velocity Percutaneous Arteriovenous Fistula (pAVF) System, a new minimally invasive method for creating dialysis access.
- Conditions
- Chronic Kidney Disease, Hemodialysis Access, Arteriovenous Fistula, End Stage Renal Disease (ESRD)
- Trial name
- VENOS-3 (NCT07153939)
- Testing
- Velocity Percutaneous Arteriovenous Fistula
- Where
- 13 sites in United States
- Volunteers
- 126 people
- Sponsor
- Venova Medical
Renal Failure, End Stage Renal Disease
Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with arteriovenous fistula (AVF) when used for hemodialysis access
- Conditions
- Renal Failure, End Stage Renal Disease, Hemodialysis, Vascular Access
- Trial name
- NCT03183245
- Testing
- Human Acellular Vessel (HAV), Arteriovenous fistula (AVF), Hemodialysis
- Where
- 31 sites in United States
- Volunteers
- 242 people
- Sponsor
- Humacyte, Inc.
Arteriovenous Fistula Stenosis
FLEX Vessel Prep Prior to Angioplasty in Native Arteriovenous Fistulae (AVF)
A prospective, multi-center, randomized observational post-market study evaluating the FLEX Vessel Prep device plus percutaneous angioplasty (PTA) vs PTA alone for the treatment of obstructive lesions in the native arteriovenous…
- Trial name
- NCT05034939
- Testing
- FLEX Vessel Prep System, Angioplasty
- Where
- 7 sites in United States
- Volunteers
- 75 people
- Sponsor
- VentureMed Group Inc.
Arterial Bleed, Pulmonary Arteriovenous Malformation
Okami Medical ALPHA Registry
This registry will provide insights into the use of Okami Medical devices in real-world clinical and study effectiveness and safety of Okami Medical devices.
- Conditions
- Arterial Bleed, Pulmonary Arteriovenous Malformation, Embolization, Hemorrhage
- Trial name
- NCT07525518
- Testing
- LOBO Vascular Occlusion System
- Where
- 6 sites in United States
- Volunteers
- 500 people
- Sponsor
- Okami Medical, Inc.
Arteriovenous Fistula Stenosis
Safety and Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis in Patients With End-Stage Diabetic Kidney Disease
A Study on the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis
- Trial name
- NCT07452822
- Testing
- Human umbilical cord mesenchymal stem cells injection, saline solution
- Volunteers
- 54 people
- Sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Hemorrhage, Bleeding
Evaluation of Peripheral EOS for the Peripheral Embolization Treatment to Rapidly OccluDe Venous or Arterial BleEding
To collect confirmatory data in support of the safety and performance of the ArtVentive Medical Group Endoluminal Occlusion System.
- Trial name
- OCCLUDE-II (NCT02033954)
- Where
- 7 sites in Austria, Belgium and 1 more
- Volunteers
- 40 people
- Sponsor
- ArtVentive Medical Group, Inc.
Brain Arteriovenous Malformation, Arteriovenous Fistula
The Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation
This study is designed as a prospective, multi-center, open-label, non-inferiority, randomized controlled clinical trial. The control device is Onyx Liquid Embolic System marketed by Micro Therapeutics Inc.
- Trial name
- PARTNER (NCT07314047)
- Testing
- liquid embolic agent
- Where
- China
- Volunteers
- 116 people
- Sponsor
- MicroPort NeuroTech Co., Ltd.
End Stage Renal Disease (ESRD)
To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis
The goal of this clinical trial is to compare the number of catheter-free days (CFD) and the rate and severity of any dialysis access-related infections between the ATEV and AVF groups over 12 months in patients with end-stage…
- Trial name
- NCT05908084
- Testing
- Acellular Tissue Engineered Vessel (ATEV), AVF
- Where
- 32 sites in United States
- Volunteers
- 121 people
- Sponsor
- Humacyte, Inc.
Complication of Renal Dialysis, End Stage Renal Disease
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index…
- Conditions
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD
- Trial name
- ACCESS (NCT02513303)
- Testing
- Sirolimus, AV Fistula Surgery, Sirolimus-eluting Collagen Implant (SeCI)
- Where
- 4 sites in United States
- Volunteers
- 269 people
- Sponsor
- Vascular Therapies, Inc.
Fistulas Arteriovenous
A Safety and Efficacy Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With DissolveAV
Drug-coated balloons delivering paclitaxel at the angioplasty site have proved their superiority in the treatment of coronary and peripheral arterial stenoses.
- Trial name
- DissolveAVF (NCT04226599)
- Testing
- Dissolve AVF, Armada 35
- Where
- 10 sites in China
- Volunteers
- 220 people
- Sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
Needle Phobia, Phobic Disorders
Effect of Including Synera® in Discussions on Dialysis Access Conversion in Patients With Needle Phobias
An arteriovenous fistula or graft access (AVF/AVG) for dialysis is often considered a superior option for delivery of dialysis, but requires needles to be inserted.
- Trial name
- NCT01623583
- Testing
- Enhanced Needle Phobia Intervention, Standard Needle Phobia Intervention
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Davita Clinical Research
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 (CKD)
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction (IR)
The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) including coiling of the brachial vein during the…
- Trial name
- NCT02119832
- Testing
- Endovasccular AVF (EndoAVF)
- Where
- Paraguay
- Volunteers
- 17 people
- Sponsor
- C. R. Bard
Arteriovenous Fistula
Post Approval Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
The objective of this study is to collect post-market, real-world safety and effectiveness data of the COVERA Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous…
- Trial name
- NCT04261686
- Testing
- Covera Vascular Covered Stent
- Where
- 11 sites in United States
- Volunteers
- 100 people
- Sponsor
- C. R. Bard
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
Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
First-In-Man Single Arm Prospective Study to assess the safety and efficacy of ULTRAVIOLET UHP PTA balloon.
- Trial name
- ULTRAVIOLETFIM (NCT07330817)
- Testing
- PTA balloon
- Where
- Italy
- Volunteers
- 35 people
- Sponsor
- Cardionovum GmbH
Arteriovenous Fistula, Arteriovenous Graft
Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients
This is a two stage, prospective, multi-center study to evaluate the EchoMark and EchoSure devices in patients undergoing peripheral arteriovenous fistula creation for hemodialysis access.
- Trial name
- NCT04017910
- Testing
- EchoMark/EchoSure
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Sonavex, Inc.
Hemodialysis Access
Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use
Vascugel™ is safe when placed at the anastomotic site at the time of surgery during creation of an AV graft or fistula for hemodialysis access.
- Trial name
- NCT00479180
- Testing
- Vascugel
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Pervasis Therapeutics, Inc