Clinical trials: Hemodialysis Access
Chronic Kidney Disease (CKD)
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol FLEX-1-001
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) in patients requiring chronic hemodialysis.
- Trial name
- NCT02119845
- Testing
- Endovascular AVF (EndoAVF)
- Where
- Paraguay
- Volunteers
- 16 people
- Sponsor
- C. R. Bard
Hemodialysis Access Failure
Prospective, Multicenter, Non-randomized, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of e-PTFE Grafts Inner Surface-treated With Paclitaxel as an Access for Hemodialysis in Patients With End-stage Renal Disease.
This prospective, multicenter, non-randomized, single-arm Clinical trial aims to evaluate the safety and effectiveness of the use of paclitaxel-coated arteriovenous graft (AVG) on the inner wall of ePTFE graft, which is designed…
- Trial name
- NCT04285073
- Testing
- Paclitaxel-eluting graft
- Where
- South Korea
- Volunteers
- 20 people
- Sponsor
- Samsung Medical Center
End Stage Renal Disease
Xeltis Hemodialysis Access Graft (aXess) US Study
A multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the aXess graft in subjects aged 18 and above, diagnosed with end-stage kidney disease, and…
- Trial name
- NCT06494631
- Testing
- Xeltis Hemodialysis Access (aXess) graft
- Where
- 7 sites in United States
- Volunteers
- 140 people
- Sponsor
- Xeltis
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.
Hemodialysis Arteriovenous Fistula Maturation Failure
Access Flow Based Intervention for Management of Arteriovenous Hemodialysis Access Dysfunction.
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.
- Trial name
- FBI (NCT02628119)
- Testing
- Intra-procedural access flow, Standard Angioplasty
- Where
- Saudi Arabia
- Volunteers
- 140 people
- Sponsor
- King Faisal Specialist Hospital & Research Center
End Stage Renal Disease
Preliminary Safety of The TRUE Vascular Graft for Hemodialysis Access (TRUE HD I Study)
Prospective, nonrandomized, single-arm, single-center, open-label, first-in-human clinical study in subjects with end-stage renal disease (ESRD) and not candidates for an autogenous fistula creation.
- Trial name
- NCT04905511
- Testing
- natural human collagen arteriovenous graft for hemodialysis access
- Where
- Paraguay
- Volunteers
- 10 people
- Sponsor
- Vascudyne, Inc.
Renal Dialysis, Hemodynamics
The LIPMAT Study: Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation
This study will investigate if liposomal prednisolone is effective in promoting arteriovenous fistula (AVF) maturation when administered to human subjects after surgical creation of a radio-cephalic AVF.
- Conditions
- Renal Dialysis, Hemodynamics, Vascular Remodeling, Neointima
- Trial name
- LIPMAT (NCT02495662)
- Testing
- PEG-liposomal prednisolone sodium phosphate
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- Leiden University Medical Center
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.
Vascular Fistula
A Comparison of mNT-BBAVF and BCAVF in Hemodialysis Patients
A well-functioning vascular access is essential for effective hemodialysis. The native arteriovenous fistula (AVF) is the preferred vascular access because of the lower thrombosis and infection risks compared to either synthetic…
- Trial name
- NCT02519933
- Testing
- mNT-BBAVF, BCAVF
- Where
- 2 sites in United States, China
- Volunteers
- 84 people
- Sponsor
- Shanghai 10th People's Hospital
Hemodialysis Fistula Thrombosis
Evaluation of Heparin Bonded Vascular Graft Versus Standard Graft in Prosthetic Arteriovenous Access for Hemodialysis
The majority of bridge graft fistula with polytetrafluoroethylene (PTFE) for hemodialysis access will develop stenosis at the venous anastomosis and eventually will fail.
- Trial name
- NCT00737620
- Testing
- Prosthetic AV graft implantation
- Where
- Israel
- Volunteers
- 160 people
- Sponsor
- Shaare Zedek Medical Center
End Stage Kidney Disease
The Vascutek Rapidax™ II Post Market Surveillance Registry
Multicentre, prospective, observational post-market registry. To monitor and collect data on the post-market clinical safety and performance of the Vascutek Rapidax II Vascular Access Graft.
- Trial name
- NCT01977508
- Testing
- ePTFE vascular access grafts
- Where
- 3 sites in Germany
- Volunteers
- 24 people
- Sponsor
- Vascutek Ltd.
Kidney Failure, Chronic, Vascular Access Devices
Efficacy of Urokinase Containing Locking Solutions for Thrombotic Dysfunction of Tunneled Hemodialysis Catheters
Thrombotic dysfunction is a common complication of tunneled cuffed catheters (TCC) leading to inadequate dialysis dose, need to catheter replacement with as consequence progressive exclusion of vascular sites.
- Trial name
- NCT02770560
- Testing
- Urokinase locking solution
- Where
- Belgium
- Volunteers
- 148 people
- Sponsor
- Universitair Ziekenhuis Brussel
End-stage Kidney Failure
ACCESS HD: Comparing Catheters to Fistulas in Elderly Patients Starting Hemodialysis
This randomized controlled trial (RCT) is multi-center, parallel-arm, and open label. It will test the feasibility and safety of randomizing elderly patients with end-stage kidney failure starting hemodialysis with a…
- Trial name
- ACCESS HD (NCT02675569)
- Testing
- Catheter, Fistula
- Where
- 13 sites in Australia, Canada
- Volunteers
- 100 people
- Sponsor
- University of Calgary
Catheter Related Blood Stream Infection, Hemodialysis
Antimicrobial Locks for Hemodialysis Catheter Infections
Tunneled hemodialysis catheters are susceptible to infection with high incidence of complication to the hemodialysis patients .The study aimed to prevent catheter infection through comparing use of antimicrobial solution…
- Conditions
- Catheter Related Blood Stream Infection, Hemodialysis, Vascular Access
- Trial name
- NCT07074821
- Testing
- Taurolidine citrate 4% and heparin 500
- Where
- Oman
- Volunteers
- 100 people
- Sponsor
- Oman Ministry of Health
Arteriovenous Graft
An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Placement of an Arteriovenous Graft to Facilitate Hemodialysis Access
A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in extending the duration of primary patency after arteriovenous graft surgery in subjects with end-stage renal disease.
- Trial name
- NCT01806584
- Testing
- SRM003, Participating Site's standard practice
- Where
- 46 sites in United States
- Volunteers
- 32 people
- Sponsor
- Shire
Decision Tree Analysis
Clinical Decision Tree Analysis of Hemodialysis Arteriovenous Access Choices and Creations - a Multiple-center Retrospective Cohort Study
Our study aim was to utilize a decision tree analysis (DTA) model to gain insight into the decision-making process within a multiple-center cohort.
- Trial name
- NCT06364449
- Testing
- No intervention
- Where
- Taiwan
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
Peripheral Artery Disease, Popliteal Aneurysm
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
- Conditions
- Peripheral Artery Disease, Popliteal Aneurysm, Hemodialysis Access, Visceral Artery Aneurysms
- Trial name
- NCT04907240
- Testing
- GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
- Where
- 26 sites in Belgium, France and 7 more
- Volunteers
- 614 people
- Sponsor
- W.L.Gore & Associates
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
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
Kidney Failure, Chronic
Arteriovenous Fistula Tissue Bank for Pre- and Post-Fistula Placement Specimens
This project will bank sera, DNA and vascular specimens from patients undergoing arteriovenous fistula creation and revision.
- Trial name
- NCT00836862
- Testing
- Biologic specimens
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- University of Nebraska