Clinical trials: Hemodialysis Access
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
Patients With an Aneurysm of Native Vascular Access Indicated for Surgical Treatment
Aneurysmorrhaphy of Vascular Access for Haemodialysis
In patients with chronic renal failure, a well-functioning vascular access is essential for hemodialysis treatment. Native arteriovenous fistula (AVF) is the first-choice of vascular access, due to a lower incidence of…
- Trial name
- AVAH (NCT03262467)
- Testing
- Aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun)
- Where
- Czechia
- Volunteers
- 115 people
- Sponsor
- Faculty Hospital Kralovske Vinohrady
Vascular Access
Early Feasibility Study to Assess the Safety and Effectiveness of the OnePoint Dialysis CannulaTM as a Single-Site Vascular Access Device for Hemodialysis Procedures
This is an early feasibility, pre-market, prospective, interventional, single-arm, non-randomized / open-label study intended to support a future pivotal IDE study for eventual FDA clearance of the study device based on the…
- Trial name
- ONEPOINT-01 (NCT07599085)
- Testing
- OnePoint Dialysis Cannula
- Volunteers
- 20 people
- Sponsor
- Evolve Medicus, Inc.
End Stage Kidney Disease (ESRD)
STARgraft (10401) Pilot
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft (10401) hemodialysis access graft.
- Trial name
- NCT07555717
- Testing
- STARgraft (10401)
- Where
- Paraguay
- Volunteers
- 20 people
- Sponsor
- Healionics Corporation
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
End Stage Renal Disease, Hemodialysis
Oxidative Stress and Hemodialysis Access Failure
Complications of hemodialysis access are the most frequent single reason for hospitalization among patients with End Stage Renal Disease (ESRD).
- Trial name
- NCT00410449
- Testing
- Alpha tocopherol
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- National Institute of Environmental Health Sciences (NIEHS)
Dialysis Access Malfunction
Continued Access Study VIG Anastomotic Connector
The continued access study of the InterGraft Venous Anastomotic Connector (Venous InterGraft Continued Access Study, or 'VIG-CAS') allows for continued enrollment of subjects while the marketing application is being prepared and…
- Trial name
- VIG-CAS (NCT05448950)
- Testing
- VIG Continued Access Study
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Phraxis, Inc.
Renal Failure, End Stage Renal Disease
Safety and Efficacy Assessment of HAV in Patients Needing Vascular Access for Dialysis
This is a Phase 2, prospective, multicenter, open-label, single-arm study of the Human Acellular Vessel (HAV).
- Conditions
- Renal Failure, End Stage Renal Disease, Vascular Access, Hemodialysis
- Trial name
- NCT04135417
- Testing
- HAV
- Where
- 2 sites in Poland
- Volunteers
- 30 people
- Sponsor
- Humacyte, Inc.
Hemodialysis Access
Cannulation-Related Pain in Dialysis Patients With Arteriovenous Fistula
It was conducted to investigate the effect of ice application to the kaleidoscope and hoku point on the management of cannulization-related pain in patients receiving hemodialysis treatment.
- Trial name
- AVF (NCT06236867)
- Testing
- KaleidoscopeGroup, Ice Application Group, Control Group
- Where
- Turkey (Türkiye)
- Volunteers
- 102 people
- Sponsor
- Sülayman YAMAN
End Stage Renal Disease, Vascular Access Patency
Determine the Safety/Efficacy of Ticagrelor for Maintaining Patency of Arterio-Venous Fistulae Created for Hemodialysis
This study is a randomized, placebo-controlled, single blind clinical trial. Seventy patients with ESRD on chronic HD and a functioning AVF will be recruited.
- Trial name
- NCT02335099
- Testing
- ticagrelor
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- University of Virginia
Hemodialysis, Clinical Assessment
Contactless Optical Monitoring of AV Access Using the PatenSee System in Outpatient Hemodialysis Patients
This is a prospective, non-interventional, single arm, international multicenter study in which up to 120 adult participants with kidney failure requiring regular hemodialysis through arteriovenous (AV) access (AV fistula or…
- Trial name
- NCT07194395
- Testing
- PatenSee System
- Where
- 2 sites in United States, Israel
- Volunteers
- 90 people
- Sponsor
- PatenSee Ltd.
End Stage Renal Disease, Venous Stenosis
Sirolimus Use in Angioplasty for Vascular Access Extension
Dialysis patients presenting for angioplasty intervention for graft failure will be randomized to receive either Sirolimus or not receive Sirolimus (standard of care) to assess the time from primary failure or angioplasty…
- Trial name
- SAVE (NCT01595841)
- Testing
- Sirolimus
- Where
- Canada
- Volunteers
- 17 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
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
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
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, Prosthetic Arteriovenous Access
Immediate Maintained Cannulation of a Newly Implanted Prosthetic Arteriovenous Access for Acute Hemodialysis
Objectives: Examine the acute utility of immediate maintained cannulations of a newly implanted prosthetic arteriovenous access. Background: Recurrent failure of central catheterization is not uncommon.
- Trial name
- NCT00711750
- Where
- Taiwan
- Volunteers
- 39 people
- Sponsor
- Far Eastern Memorial Hospital
Stenoses
Pivotal Study for the FLAIR Endovascular Stent Graft
This study compared the FLAIR™ Endovascular Stent Graft to balloon angioplasty in patients with stenoses at the venous anastomosis of a synthetic AV access graft.
- Trial name
- NCT00678249
- Testing
- FLAIR Endovascular Stent Graft, PTA
- Where
- United States
- Volunteers
- 227 people
- Sponsor
- C. R. Bard
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
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
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