Clinical trials: Hemodialysis Access Failure
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
Vascular Access Complication, Hemodialysis Access Failure
Optimizing Access Surgery In Senior Hemodialysis Patients
The number of elderly hemodialysis patients is growing. Vascular access complications are a major determinant of the quality of life and health care costs for these vulnerable patients.
- Conditions
- Vascular Access Complication, Hemodialysis Access Failure, Dialysis Access Malfunction, Arteriovenous Fistula
- Trial name
- OASIS (NCT05911451)
- Testing
- Arteriovenous fistula creation, Arteriovenous graft placement, Central venous catheter placement
- Where
- 20 sites in Netherlands
- Volunteers
- 166 people
- Sponsor
- Maastricht 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.
End Stage Renal Disease, Hemodialysis Vascular Access Failure
Reduction of Plasma Free VEGF-A Using Low-dose Bevacizumab in Hemodialysis Patients
The primary purpose of this pilot study is to assess the pharmacokinetic profile of low-dose bevacizumab and its effectiveness in reducing plasma free VEGF-A levels safely in hemodialysis patients.
- Trial name
- NCT02695641
- Testing
- 1.25mg bevacizumab, 2.50mg bevacizumab
- Sponsor
- Mayo Clinic
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
End Stage Renal Failure, Hemodialysis, Vascular Access
Comparison of Tunneled Cuffed Dialysis Catheters Versus Arteriovenous Fistulae in Elderly or Multimorbid Patients
Patients are randomly assigned to a study group. Depending on the study group, either an arteriovenous fistula or tunneled cuffed catheter (TCC) will be implanted, followed by continuous evaluation of the patients during the…
- Conditions
- End Stage Renal Failure, Hemodialysis, Vascular Access, Fistulas Arteriovenous, Haemodialysis Complication
- Trial name
- NCT07649083
- Testing
- Tunneled cuffed catheter (TCC) will be implanted for chronic haemodialysis treatment, Arteriovenous fistula creation for chronic haemodialysis treatment
- Volunteers
- 220 people
- Sponsor
- Medical University of Vienna
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.
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
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
Hemodialysis Access Failure, Kidney Disease, End-Stage
Low-Dose Apixaban Added to Standard Heparin Lock Versus Heparin Lock Alone to Prevent Tunneled Hemodialysis Catheters Dysfunction (APICATH-HD)
This randomized, single-center, PROBE trial evaluates whether adding low-dose apixaban (2.5 mg orally every 12 hours) to standard intraluminal heparin lock prolongs primary functional patency of tunneled hemodialysis catheters…
- Conditions
- Hemodialysis Access Failure, Kidney Disease, End-Stage, Hemodialysis Catheter
- Trial name
- APICATH-HD (NCT07404345)
- Testing
- Apixaban, Heparin sodium lock solution
- Where
- Mexico
- Volunteers
- 54 people
- Sponsor
- Hospital Civil de Guadalajara
Dialysis Access Malfunction, Hemodialysis Access Failure
Flow Dysfunction of Hemodialysis Vascular Access
The FLOW trial evaluates the follow-up of the vascular access for hemodialysis. In current clinical care, vascular access flow volume is periodically assessed to detect and treat asymptomatic stenosis.
- Conditions
- Dialysis Access Malfunction, Hemodialysis Access Failure, Hemodialysis Fistula Thrombosis, Vascular Access Malfunction
- Trial name
- FLOW (NCT05906550)
- Testing
- Vascular access monitoring, Vascular access blood flow measurement
- Where
- 13 sites in Netherlands
- Volunteers
- 375 people
- Sponsor
- Maastricht University Medical Center
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.
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.
End Stage Renal Failure, Hemodialysis Access Failure
Outcomes for One-stage and Two-stage Brachial Basilic Arteriovenous Fistulas
An arteriovenous (AV) fistula is essential for patients with kidney failure on dialysis. There is no clear data on the best method to create a new brachial basilic AV fistula (BBAVF), so the choice between a single procedure and…
- Conditions
- End Stage Renal Failure, Hemodialysis Access Failure, Arterio-venous Fistula
- Trial name
- NCT04376567
- Testing
- One stage approach
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Tze-Woei Tan
Arteriovenous Fistula, Pain
Evaluating the Effect of the Valsalva Maneuver on Invasive Pain During Arteriovenous Fistula Cannulation in Hemodialysis Patients
The goal of this clinical trial is to evaluate whether the Valsalva maneuver reduces invasive pain during arteriovenous fistula (AVF) cannulation in adult hemodialysis patients.
- Conditions
- Arteriovenous Fistula, Pain, Hemodialysis Access Failure, Vascular Access Device Complications
- Trial name
- VALPAIN-HD (NCT07066579)
- Testing
- Valsalva Maneuver
- Volunteers
- 60 people
- Sponsor
- Cansu POLAT DÜNYA
Chronic Kidney Disease, Hemodialysis
Skill Building Education of Arteriovenous-Fistula Self-Care Behaviors and Quality of Life of Patients on Hemodialysis
The purpose of this study is to assess the effectiveness of skill building educational interventions in improving the self-care behaviors and quality of life of AVF in hemodialysis patients. This study will address questions.
- Conditions
- Chronic Kidney Disease, Hemodialysis, Hemodialysis Access Failure
- Trial name
- NCT06947772
- Testing
- Skill building education
- Where
- Pakistan
- Volunteers
- 274 people
- Sponsor
- Shifa Tameer-e-Millat University
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
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.
Hemodialysis, Thrombolytic Therapy
Comparison of Standard Versus High Dose Urokinase for Dysfunctional Tunneled Dialysis Catheters in Haemodialysis Patients: A Randomized Controlled Trial
Tunneled dialysis catheters (TDCs) remain a frequent form of vascular access for patients undergoing long-term haemodialysis (HD).
- Conditions
- Hemodialysis, Thrombolytic Therapy, Dialysis Access Dysfunction, Randomised Controlled Trial
- Trial name
- SHUT (NCT06802679)
- Testing
- Urokinase
- Where
- Singapore
- Volunteers
- 44 people
- Sponsor
- National Healthcare Group, Singapore