Clinical trials: Arteriovenous Fistula
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
Venous Stenosis, Venous Occlusion
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
The WRAP Study aims to expand and understand the safety and efficacy data on the WRAPSODY Endoprosthesis System in a real-world population.
- Trial name
- NCT05062291
- Testing
- Merit WRAPSODY Endovascular Stent Graft
- Where
- 35 sites in Australia, Brazil and 7 more
- Volunteers
- 500 people
- Sponsor
- Merit Medical Systems, Inc.
Complication of Renal Dialysis, End Stage Renal Disease
A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery
The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an…
- Conditions
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD
- Trial name
- ACCESS2 (NCT05425056)
- Testing
- Sirolimus
- Where
- 22 sites in United States, United Kingdom
- Volunteers
- 136 people
- Sponsor
- Vascular Therapies, Inc.
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
Venous Stenosis, Venous Occlusion
WRAP North America
The goal of this observational study is to investigate the safety and efficacy of the WRAPSODY CIE in a real-world North American population.
- Trial name
- NCT06807099
- Testing
- Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)
- Where
- 16 sites in United States, Canada
- Volunteers
- 250 people
- Sponsor
- Merit Medical Systems, Inc.
Kidney Disease, End-Stage, End-stage Renal Disease
Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
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.
- Conditions
- Kidney Disease, End-Stage, End-stage Renal Disease, Arteriovenous Fistula
- Trial name
- CONNECT-AV (NCT04634916)
- Testing
- EndoAVF Creation
- Where
- 17 sites in United States, Australia
- Volunteers
- 220 people
- Sponsor
- C. R. Bard
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
- 4 sites in United States
- Volunteers
- 500 people
- Sponsor
- Okami Medical, Inc.
Aneurysm, Endoleak
Cera™ Vascular Plug System Post-Market Clinical Follow-Up
The objective of the study is to collect and evaluate clinical data on patients of the Lifetech Cera™ Vascular Plug System to: confirm the performance confirm the safety identify previously unknown side-effects monitor the…
- Conditions
- Aneurysm, Endoleak, Pulmonary Arteriovenous Malformation, Portal Hypertension
- Trial name
- NCT06099015
- Testing
- Cera™ Vascular Plug System
- Where
- 9 sites in Germany, Italy and 1 more
- Volunteers
- 132 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Venous Stenosis, Venous Occlusion
The Merit WRAPSODY AV Access Efficacy Study (WAVE)
The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit
- Trial name
- WAVE (NCT04540302)
- Testing
- Merit WRAPSODY Endovascular Stent Graft, PTA
- Where
- 43 sites in United States, Brazil and 2 more
- Volunteers
- 357 people
- Sponsor
- Merit Medical Systems, Inc.
Renal Disease, End Stage, Kidney Disease, End-Stage
Ellipsys Vascular Access System Post Market Surveillance (PS) Study
The proposed clinical study is a prospective, non-randomized, multi-center, single-arm, observational, post-market surveillance (PS) study of the Ellipsys Vascular Access System in subjects eligible for arteriovenous (AV) fistula.
- Conditions
- Renal Disease, End Stage, Kidney Disease, End-Stage, AV Fistula, Fistulas Arteriovenous
- Trial name
- NCT04484220
- Testing
- Ellipsys Vascular Access System
- Where
- 12 sites in United States
- Volunteers
- 142 people
- Sponsor
- Medtronic Endovascular
Arterio-Venous Fistula, ESRD
VasQ External Support for Arteriovenous Fistula
This is a prospective clinical study of the VasQ external support for arteriovenous fistulas. The device is designed to improve fistula outcomes by optimizing the geometrical configuration of the fistula, influencing…
- Conditions
- Arterio-Venous Fistula, ESRD, Steal Syndrome, Aneurysm
- Trial name
- NCT03242343
- Testing
- VasQ
- Where
- 15 sites in United States
- Volunteers
- 144 people
- Sponsor
- Laminate Medical Technologies
Kidney Diseases, Arteriovenous Fistula
Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae
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.
- Trial name
- NCT04896476
- Testing
- EchoMark / EchoSure
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- Sonavex, Inc.
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
Intracranial Aneurysm, AVM - Cerebral Arteriovenous Malformation
Postmarket Study of Tarvos Microguidewire in Neurovascular Interventional Surgery
This investigation is to evaluate the clinical effectiveness and safety of the Tarvos Microguidewire in the neurovascular interventional surgery.
- Conditions
- Intracranial Aneurysm, AVM - Cerebral Arteriovenous Malformation, AV Fistula, Acute Ischemic Stroke
- Trial name
- NCT07500155
- Testing
- Tarvos Microguidewire
- Where
- China
- Volunteers
- 121 people
- Sponsor
- Keuro MedTech
Arteriovenous Fistula
Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae
This prospective, global, multicenter, single arm post-approval study is designed to investigate the clinical use and safety of the Lutonix® 035 AV Drug Coated Balloon (DCB) PTA Catheter in subjects presenting with clinical and…
- Trial name
- AVPAS (NCT03506308)
- Testing
- LUTONIX 035 Drug Coated Balloon PTA Catheter
- Where
- 26 sites in United States, Canada
- Volunteers
- 213 people
- Sponsor
- C. R. Bard
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.
Chronic Kidney Diseases, End Stage Renal Disease
SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a…
- Conditions
- Chronic Kidney Diseases, End Stage Renal Disease, Arteriovenous Fistula, Hemodialysis Access Failure
- Trial name
- SAVE-FistulaS (NCT06001827)
- Testing
- SelfWrap Bioabsorbable Perivascular Wrap, Untreated AVF Control
- Where
- 28 sites in United States
- Volunteers
- 600 people
- Sponsor
- VenoStent
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.
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
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