Clinical trials: Hemodialysis Access
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.
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
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
Preliminary Safety of The TRUE Vascular Graft for Hemodialysis Access (TRUE HD I Study)
Prospective, nonrandomized, single-arm, single-center, open-label, first-in-human clinical study in subjects with end-stage renal disease (ESRD) and not candidates for an autogenous fistula creation.
- Trial name
- NCT04905511
- Testing
- natural human collagen arteriovenous graft for hemodialysis access
- Where
- Paraguay
- Volunteers
- 10 people
- Sponsor
- Vascudyne, Inc.
Dialysis; Complications, Vascular Access Complication
Access Cannulation Trial II
This is a pivotal, interventional, prospective, single-arm, open-label, multi-site clinical investigation intended to support FDA clearance of the study device based on the safety and efficacy of the device in cannulating…
- Trial name
- ACT II (NCT05490225)
- Testing
- VenaSure
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- Voyager Biomedical
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
End Stage Renal Disease
Evaluation of STARgraft AV for Hemodialysis Access
This study is a First-in-Human, single site, prospective, randomized, controlled evaluation of the safety and effectiveness of the Healionics STARgraft AV hemodialysis access graft.
- Trial name
- NCT03916731
- Testing
- STARgraft AV, ePTFE AV graft (control)
- Where
- Paraguay
- Volunteers
- 55 people
- Sponsor
- Healionics Corporation
Renal Insufficiency,Chronic
BEACH Trial: Bovine Early Access, Compatibility and Hemostasis Trial
Bovine Early Access, Compatibility, and Hemostasis (BEACH) Trial Study is to evaluate the Safety and Effectiveness of Early Access in Patients Who Require an Arteriovenous Conduit for Hemodialysis using the Artegraft® Collagen…
- Trial name
- BEACH (NCT04146012)
- Testing
- Artegraft® Collagen Vascular Graft™ (Artegraft)
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- Artegraft, Inc.
Renal Failure Chronic Requiring Hemodialysis
Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study
Compare the HeRO Vascular Access Device to a conventional ePTFE graft.
- Trial name
- NCT00890045
- Testing
- HeRO Vascular Access Device, Conventional ePTFE hemodialysis graft
- Where
- 11 sites in United States
- Volunteers
- 72 people
- Sponsor
- Merit Medical Systems, Inc.
Chronic Kidney Disease
A Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
The purpose of this study is to determine if PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery to create an arteriovenous fistula is safe and improves the patency of your…
- Trial name
- NCT01305824
- Testing
- PRT-201
- Where
- 23 sites in United States
- Volunteers
- 151 people
- Sponsor
- Proteon Therapeutics
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.
Kidney Diseases, ESRD
Safety and Efficacy of Angiotech Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access
This is a multi-center clinical study in subjects requiring arteriovenous grafts in the upper extremity for hemodialysis access. All subjects will provide informed consent before undergoing any study procedures.
- Trial name
- NCT00448708
- Testing
- Vascular Wrap Paclitaxel-Eluting Mesh, Lifespan® ePTFE Vascular Graft
- Where
- 33 sites in United States
- Volunteers
- 222 people
- Sponsor
- Angiotech Pharmaceuticals
Chronic Kidney Disease (CKD)
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction (IR)
The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) including coiling of the brachial vein during the…
- Trial name
- NCT02119832
- Testing
- Endovasccular AVF (EndoAVF)
- Where
- Paraguay
- Volunteers
- 17 people
- Sponsor
- C. R. Bard
End Stage Renal Disease
Initial Safety Study of the TRUE AVC in Hemodialysis Access (TRUE AVC I Study)
Prospective, nonrandomized, single-arm, single-center, open-label, initial safety study in subjects requiring hemodialysis. Subjects will be followed with physical evaluation and ultrasound vessel imaging at days 15, 29, 57 and…
- Trial name
- NCT05567757
- Testing
- Arteriovenous conduit implant
- Where
- Panama
- Volunteers
- 11 people
- Sponsor
- Vascudyne, Inc.
Chronic Kidney Diseases, End Stage Renal Disease on Dialysis
Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access
The goal of this observational study is to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis.
- Trial name
- AVG22-09 (NCT05846581)
- Testing
- GORE® ACUSEAL Vascular Graft
- Where
- 4 sites in Germany, Italy and 1 more
- Volunteers
- 72 people
- Sponsor
- W.L.Gore & Associates