Clinical trials: Hemodialysis Access Failure, active
Hemodialysis Access Failure
Effectiveness of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure
This study was aimed at comparing the efficacy and safety of cutting balloons versus drug-coated balloons in treating venous segment stenosis of autologous arteriovenous fistulas.This is a prospective, multi-center cohort study.
- Trial name
- NCT06493292
- Testing
- Endovascular therapy
- Where
- 3 sites in China
- Volunteers
- 180 people
- Sponsor
- RenJi Hospital
Arteriovenous Fistula, Angioplasty, Balloon
DRug-coAted Balloon Compared With cuttinG balloON in Treatment of Arteriovenous Fistula Stenosis
The purpose of this clinical trial is to compare the efficacy and safety of cutting balloons versus drug-coated balloons in treating venous stenosis of autologous arteriovenous fistulas.The main questions it aims to answer are…
- Conditions
- Arteriovenous Fistula, Angioplasty, Balloon, Hemodialysis Access Failure
- Trial name
- Dragon (NCT06527963)
- Testing
- Endovascular therapy
- Where
- 3 sites in China
- Volunteers
- 180 people
- Sponsor
- RenJi Hospital
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
Chatbot-Based Training, Hemodialysis
DialysisBot: AI Chatbot for Hemodialysis Self-Management
End-stage kidney disease requiring hemodialysis is a chronic condition with substantial clinical, functional, and psychosocial burden.
- Conditions
- Chatbot-Based Training, Hemodialysis, Self-management
- Trial name
- NCT07830810
- Testing
- DialysisBot
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- University of Rome Tor Vergata
Endovascular Procedure, Hemodialysis
Medico-economic Evaluation of the Creation of Arteriovenous Access for Hemodialysis Between Surgical Technique and Endovascular Technique in Patients with End-stage Renal Disease
This multicenter 1 :1 randomized controlled trial aims at comparing the cost-effectiveness of endovascular arteriovenous fistula (AVF) creation using Ellipsys® and WaveLinQ® devices with traditional surgical AVF creation for…
- Trial name
- ENDOFAV (NCT06679907)
- Testing
- WaveLinQ® device, Ellipsys® device, No device
- Where
- 11 sites in France
- Volunteers
- 252 people
- Sponsor
- University Hospital, Bordeaux
Hemodialysis Access Failure
Effectiveness and Health Economics of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure
This study was aimed at evaluating the efficacy of different endovascular treatments for early and mid-stage clinical interventions in patients with autologous arteriovenous fistulae loss of function and the corresponding health…
- Trial name
- NCT06454396
- Testing
- Endovascular therapy
- Where
- China
- Volunteers
- 480 people
- Sponsor
- RenJi Hospital
End Stage Renal Disease (ESRD), Kidney Failure
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
The goal of the CSP-2002 clinical trial is to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis (HD) access in patients with end-stage renal disease (ESRD).
- Conditions
- End Stage Renal Disease (ESRD), Kidney Failure, Chronic Renal Disease, Hemodialysis
- Trial name
- NCT04671771
- Testing
- InnAVasc Arteriovenous Graft (IG) surgical implant
- Where
- 22 sites in United States
- Volunteers
- 133 people
- Sponsor
- W.L.Gore & Associates
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
End Stage Renal Disease
Evaluation of STARgraft-3 for Hemodialysis
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-3 hemodialysis access graft.
- Trial name
- NCT05729620
- Testing
- Implant of STARgraft-3 shunt in the upper arm and subsequent use for hemodialysis access
- Where
- Paraguay
- Volunteers
- 21 people
- Sponsor
- Healionics Corporation
Hemodialysis Complication, Dialysis Access Malfunction
Six-month Response Rate According to Two Surgical Techniques (Rotational Atherectomy Versus Angioplasty) to Treat Stenosis of Vascular Accesses in Hemodialysis.
A well-functioning hemodialysis vascular access is a decisive factor in the survival of hemodialysis patients, who have a high mortality rate. 85% of these hemodialysis patients, are treated via an arteriovenous fistula (AVF).
- Conditions
- Hemodialysis Complication, Dialysis Access Malfunction, Stenosis
- Trial name
- ARSAV (NCT06868901)
- Testing
- Standard angioplasty + drug-eluting balloon technique, Atherectomy + drug-eluting balloon
- Volunteers
- 40 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
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
Chronic Kidney Diseases, Dialysis; Complications
AVF Awareness Among Advanced CKD Patients
This cross-sectional study aims to assess awareness regarding arteriovenous fistula creation among patients with advanced chronic kidney disease, including pre-dialysis patients and those receiving maintenance hemodialysis, at…
- Conditions
- Chronic Kidney Diseases, Dialysis; Complications, Arteriovenous Fistula, Kidney Failure, Chronic
- Trial name
- NCT07817953
- Volunteers
- 116 people
- Sponsor
- Assiut University
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 (ESRD), Brachiocephalic Fistula (BCF)
Outcome of BCF Access in Hemodialysis Patients
Dialysis access, which is the connection that allows blood to flow in and out of the body during dialysis sessions, is important to remove wastes and excess fluid for patients with end stage renal disease (ESRD).
- Conditions
- End Stage Renal Disease (ESRD), Brachiocephalic Fistula (BCF), Cephalic Arch Stenosis (CAS), Dialysis
- Trial name
- BCF (NCT01693263)
- Testing
- brachiocephalic fistula (BCF)
- Where
- United States
- Volunteers
- 96 people
- Sponsor
- University of Chicago
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, 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
Pulmonary Hypertension (PH), End Stage Kidney Disease (ESRD)
Euvolemia-Based Assessment of Pulmonary Hypertension in Stable Hemodialysis Patients
Pulmonary hypertension (PH) is a frequent and clinically significant complication in patients with end-stage kidney disease (ESKD) undergoing maintenance hemodialysis (HD).
- Conditions
- Pulmonary Hypertension (PH), End Stage Kidney Disease (ESRD), Hemodialysis Patients, Volume Overload
- Trial name
- EU-PHASE-HD (NCT07676786)
- Testing
- Observational Assessment
- Where
- 2 sites in Romania
- Volunteers
- 30 people
- Sponsor
- Stefan Lujinschi
End Stage Renal Disease
Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis
Hemodialysis represents a life line of patients with end stage renal disease, who are commonly maintained on hemodialysis through catheters.
- Trial name
- IVUS in ESRD (NCT04399941)
- Testing
- Venography, Intravascular ultrasound (IVUS), Image processing
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Boston Medical Center
End Stage Renal Disease
Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study
A prospective, single arm, non-randomized feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, in subjects older than 18 years with end-stage renal disease, who plan to…
- Trial name
- NCT06329310
- Testing
- aXess-E conduit
- Where
- 2 sites in Portugal, Serbia
- Volunteers
- 20 people
- Sponsor
- Xeltis
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