Clinical trials: Hemodialysis Access Failure
End Stage Renal Disease, End Stage Renal Failure on Dialysis
First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft
A feasibility study is to assess the preliminary safety and performance of the Xeltis hemodialysis access (aXess) graft.
- Trial name
- aXess-FIH (NCT04898153)
- Testing
- aXess
- Where
- 6 sites in Belgium, Italy and 2 more
- Volunteers
- 20 people
- Sponsor
- Xeltis
End Stage Renal Disease
Adenovirus Vascular Endothelial Growth Factor (VEGF) Therapy in Vascular Access - Novel Trinam AGainst Control Evidence
Patients in renal failure on hemodialysis depend on adequate and sustained vascular access. This can be achieved by surgical placement of a synthetic polytetrafluoroethylene (PTFE) graft.
- Trial name
- AdV-VANTAGE (NCT00895479)
- Testing
- Graft placement surgery plus Trinam therapy
- Where
- 12 sites in United States
- Volunteers
- 250 people
- Sponsor
- Ark Therapeutics Ltd
Hemodialysis Graft Dysfunction
Use of ABI-007 for the Prevention of Vascular Access Graft Failure in Patients Undergoing Hemodialysis
This study is designed to confirm the safety of the proposed dose and schedule of ABI-007 for hemodialysis patients with vascular access device failure, and to obtain preliminary data on the effectiveness of such treatment.
- Trial name
- NCT00249002
- Testing
- ABI-007
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- Celgene
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.
End Stage Renal Disease
Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access
This study is a prospective, non-randomized, multi-center evaluation of the performance of the GORE® ACUSEAL Vascular Graft. The study will enroll patients with End-Stage Renal Disease (ESRD), who are either currently receiving…
- Trial name
- ACUSEAL (NCT01173718)
- Testing
- GORE® ACUSEAL Vascular Graft
- Volunteers
- 138 people
- Sponsor
- W.L.Gore & Associates
End-Stage Renal Disease
Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry
Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,
- Trial name
- NCT05880537
- Testing
- Nexeon Arterial Venous Allograft
- Where
- 4 sites in United States
- Volunteers
- 100 people
- Sponsor
- LifeNet Health
Chronic Kidney Diseases, Chronic Kidney Failure
SelfWrap-Assisted Arteriovenous Fistulas
This is a single-center, prospective, single-arm clinical study to evaluate the feasibility, safety, and performance of VenoStent's SelfWrap® Bioabsorbable Perivascular Wrap on arteriovenous fistulas (AVFs).
- Conditions
- Chronic Kidney Diseases, Chronic Kidney Failure, End Stage Renal Disease, End Stage Kidney Disease
- Trial name
- SW-AVF (NCT05418816)
- Testing
- SelfWrap Bioabsorbable Perivascular Wrap
- Where
- Paraguay
- Volunteers
- 20 people
- Sponsor
- VenoStent
Hyperplasia, Chronic Renal Failure
Prevention of Vascular Access Graft Failure in Patients With Chronic Renal Failure Requiring Hemodialysis
The purpose of this study is to determine the effect of recipient vein pretreatment of edifoligide (E2F Decoy), compared to placebo, on graft/recipient vein stenosis in polytetrafluoroethylene (PTFE) vascular access grafts placed…
- Trial name
- NCT00086164
- Testing
- edifoligide (E2F Decoy)
- Where
- 21 sites in United States
- Sponsor
- Anesiva, Inc.
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 Disease
Evaluation of STARgraft-2 for Hemodialysis Access
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-2 hemodialysis access graft.
- Trial name
- NCT04783779
- Testing
- Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis access
- Where
- Paraguay
- Volunteers
- 24 people
- Sponsor
- Healionics Corporation
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 Disease, End-Stage
PATH-03 Paraguay Feasibility Study
The goal of this study is to evaluate the safety and effectiveness of the ePATH system in the creation of an endovascular AVF (endoAVF) in patients who require or will soon require hemodialysis and are eligible for a fistula.
- Trial name
- NCT07034092
- Testing
- ePATH System will be used to create an endoAVF
- Where
- Paraguay
- Volunteers
- 20 people
- Sponsor
- Pathfinder Medical
Chronic Kidney Diseases, Hemodialysis
Must Cannulation Technique of Vascular Access in Patients Undergoing Haemodialysis: Contributions for a Safe Nursing Intervention
The aims of this study are to: Determine the AVF (arteriovenous fistula) survival of patients submitted to MuST compared to those submitted to RL (rope-ladder).
- Conditions
- Chronic Kidney Diseases, Hemodialysis, Vascular Access Complication, Hemodialysis Access Failure
- Trial name
- MuST (NCT05081648)
- Testing
- CT MuST, Rope-ladder cannulation technique
- Where
- 3 sites in Portugal
- Volunteers
- 101 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
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.
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
Hemodialysis Access Failure
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (AVess FIH)
The purpose of this study is to evaluate the safety and performance of the SurVeil DCB in subjects with obstructive lesions of arteriovenous fistulae for hemodialysis.
- Trial name
- NCT03734679
- Testing
- SurVeil Drug Coated Balloon
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 12 people
- Sponsor
- SurModics, Inc.
End-stage Renal Disease, Kidney Failure, Chronic
Evaluation of the Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With ESRD
The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vascular Graft, HAVG.
- Trial name
- NCT01744418
- Testing
- HAVG graft implantation
- Where
- 3 sites in Poland
- Volunteers
- 40 people
- Sponsor
- Humacyte, Inc.
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.
End Stage Renal Disease (ESRD)
HeRO Graft Compared to Permanent Catheters for End Stage Renal Disease (ESRD) Patients Receiving Hemodialysis
The main objective of this research study was to compare the following outcomes between patients with a Hemodialysis Reliable Outflow (HeRO) Graft and patients with a cuffed catheter for dialysis access over one year: quality of…
- Trial name
- NCT01343251
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Merit Medical Systems, Inc.
End-Stage Renal Disease Requiring Haemodialysis, Hemodialysis Access Failure (Disorder)
BONE ANCHORED PORT for Hemodialysis Treatment
A Bone Anchored Port System (BAP) will be implanted in the mastoid bone behind the ear, connected with a double lumen central venous catheter inserted in the jugular vein, and will be used in conjunction with an adapter as a…
- Trial name
- BAP (NCT02069860)
- Testing
- Bone Anchored Port System (BAP)
- Where
- Switzerland
- Volunteers
- 6 people
- Sponsor
- Cendres+Métaux