Clinical trials: Dialysis Access Malfunction
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
Dialysis Access Malfunction, Stenosis
A Real-world Registry Investigating Sirolimus-coated Balloon Versus Paclitaxel-coated Balloon Angioplasty for the Treatment of Dysfunctional Arteriovenous Fistula
Drug-coated balloon (DCB) angioplasty has been shown to be superior to POBA in the treatment of stenosis in AVF. This is because the very intervention used to treat underlying stenosis by POBA can induce vascular injury and…
- Trial name
- SAVE AVF (NCT05333640)
- Testing
- Sirolimus Drug Coated Balloon, Paclitaxel Drug Coated Balloon
- Where
- Singapore
- Volunteers
- 200 people
- Sponsor
- Singapore General Hospital
End-stage Renal Disease
Ellipsys Vascular Access System Registry
Ellipsys Vascular Access System Registry will enroll up to 100 patients to evaluate the use and performance of the Ellipsys Vascular Access System when it is used within its intended use in accordance with standard of care in a…
- Trial name
- NCT03454113
- Testing
- Ellipsys Vascular Access
- Where
- 5 sites in Germany
- Volunteers
- 17 people
- Sponsor
- Medtronic Endovascular
Renal Dialysis, Integrative Medicine
Integrative HD Vascular Access Assessment
The aim of this two-year study is to explore the relationship among function of HVA, nail-fold capillaries and TCM constitutions based on hybridizing data mining techniques.
- Conditions
- Renal Dialysis, Integrative Medicine, Hemodialysis Access Failure
- Trial name
- NCT03140345
- Where
- Taiwan
- Volunteers
- 200 people
- Sponsor
- National Taipei University of Nursing and Health Sciences
Hemodialysis Complication, Dialysis; Complications
Handheld Ultrasound-guided Cannulation of Difficult Haemodialysis Arteriovenous Access by Renal Nurses
Cannulation of complex arteriovenous fistula (AVF) or graft (AVG) is a challenge to renal nurses. Ultrasound (US) guidance on central and peripheral venous access visualisation has been widely adopted in nephrology and shown to…
- Conditions
- Hemodialysis Complication, Dialysis; Complications, Vascular Access Site Haematoma, Vascular Access Complication
- Trial name
- NCT05410691
- Testing
- Handheld US device
- Where
- Singapore
- Volunteers
- 50 people
- Sponsor
- National Healthcare Group, Singapore
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.
Renal Failure
Restenosis Following Paclitaxel Eluting Balloon Angioplasty of Hemodialysis Access Stenosis
Introduction: Narrowing of the draining vein occurs in >50% of hemodialysis fistula and left untreated will lead to loss of access. The narrowing is due to excessive growth of tissue in the vessel wall (intimal hyperplasia).
- Trial name
- NCT01001676
- Testing
- Percutaneous Transluminal Angioplasty (PTA), Paclitaxel Eluting Balloon Angioplasty
- Where
- Canada
- Volunteers
- 32 people
- Sponsor
- University Health Network, Toronto
Neointimal Hyperplasia, Dialysis Access Malfunction
A Prospective, Randomized Controlled Trial of Stent Graft and Drug Coated Balloon Treatment for Recurrent Cephalic Arch Stenosis in Dysfunctional Arteriovenous-venous Fistula
Arteriovenous Fistula (AVF) is a surgically created circuit used for hemodialysis in patient with End Stage Renal Disease (ESRD).
- Trial name
- PREDATOR (NCT05360394)
- Testing
- Paclitaxel Coated Balloon, Paclitaxel Coated Balloon and Stent Graft
- Where
- 2 sites in Australia, Singapore
- Volunteers
- 80 people
- Sponsor
- Singapore General Hospital
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
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.
Uremic Pruritus
Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin
This is an intermediate-size patient population expanded access protocol for the use of intravenous (IV) difelikefalin for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients…
- Trial name
- NCT05031546
- Testing
- Difelikefalin
- Sponsor
- Cara Therapeutics, Inc.
Arterio-venous Fistula, Dialysis Access Malfunction
Use of Implanting the Biotronik Passeo-18 Lux Drug Coated Balloon to Treat Failing Haemodialysis Arteriovenous Fistulas and Grafts.
The most common problem with haemodialysis arteriovenous fistulas (AVF) and arterio-venous grafts (AVG) is stenosis, which can lead to inadequate dialysis, and eventual access thrombosis.
- Conditions
- Arterio-venous Fistula, Dialysis Access Malfunction, Hemodialysis Access Failure, Arteriovenous Graft Stenosis
- Trial name
- SEMPER FI (NCT04381754)
- Testing
- Passeo-18 Lux
- Where
- Singapore
- Volunteers
- 100 people
- Sponsor
- Singapore General Hospital
Kidney Failure, Renal Dialysis
Comparison of Bovine Carotid Artery and Expanded Polytetrafluoroethylene (ePTFE) for Permanent Hemodialysis Access
The investigators did a randomized control trial comparing bovine carotid artery grafts with ePTFE grafts for patients that need hemodialysis access.
- Trial name
- NCT01021839
- Testing
- Grafts placement
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Massachusetts General Hospital
Dialysis Access Malfunction
Trial Comparing Angiography and Angiography With IVUS for Treatment of Hemodialysis Access Failures
The reason the investigators are doing this study is to compare the results of angiography versus angiography with intravascular ultrasound in dialysis grafts/fistulas that are blocked.
- Trial name
- NCT02056704
- Testing
- Angiography with IVUS
- Where
- 4 sites in United States
- Volunteers
- 66 people
- Sponsor
- Baylor Research Institute
Dialysis Access Malfunction, Kidney Failure
Evaluation of Paclitaxel Coated Balloon in the Treatment of Dialysis Access Dysfunction
Recent studies of paclitaxel DCB in the treatment of stenosis at dialysis vascular access have shown promising results. Paclitaxel, an anti-proliferation drug, is released during balloon inflation and potentially improve primary…
- Trial name
- NCT04988789
- Testing
- Paclitaxel Drug Coated Balloon
- Where
- Singapore
- Volunteers
- 500 people
- Sponsor
- Singapore 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
Kidney Disease, Kidney Failure
Hemodialysis in the Elderly (70yrs & Older)
This will be a prospective, single institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing autologous arteriovenous fistula versus hemodialysis access grafts in the elderly.
- Conditions
- Kidney Disease, Kidney Failure, Chronic Kidney Disease
- Trial name
- ELDERLY (NCT03065972)
- Testing
- Surgical fistula creation from patient's anatomy, Surgical Graft implant
- Where
- United States
- Volunteers
- 270 people
- Sponsor
- E. Peden, MD
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
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 on Dialysis
Vienna Vascular Access Studied on Exchange of Dialysis Catheters for Shunts Where Feasible
We will conduct a cross-section analysis regarding patients with catheter-based vascular Access (VA) in Vienna. Collected data will include demographic and clinical information such as age, gender, co-morbidities and imaging data…
- Trial name
- ViennaACTSNOW (NCT05704140)
- Testing
- Catheter based Dialysis
- Where
- Austria
- Volunteers
- 400 people
- Sponsor
- Wilhelminenspital Vienna