Clinical trials: Arteriovenous Graft
Venous Stenosis, Venous Occlusion
The Merit WRAPSODY AV Access Efficacy Study (WAVE)
The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit
- Trial name
- WAVE (NCT04540302)
- Testing
- Merit WRAPSODY Endovascular Stent Graft, PTA
- Where
- 43 sites in United States, Brazil and 2 more
- Volunteers
- 357 people
- Sponsor
- Merit Medical Systems, Inc.
End Stage Renal Disease, Hemolysis
Bovine Carotid Artery Biologic Graft and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access
The investigators propose a randomized study to compare bovine carotid artery (BCA) biologic grafts and expanded polytetrafluoroethylene grafts (ePTFE) for permanent hemodialysis access.
- Conditions
- End Stage Renal Disease, Hemolysis, Arteriovenous Graft
- Trial name
- NCT03300024
- Testing
- Expanded polytetrafluoroethylene Graft, Bovine Carotid Artery Graft
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Johns Hopkins University
Kidney Failure, Chronic, Renal Dialysis
Evaluating the Safety and Effectiveness of the InnAVasc Graft for Dialysis Access in Patients With Kidney Failure
The CSP-1001 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for hemodialysis in participants suffering from end stage renal failure (ESRD).
- Trial name
- NCT03645681
- Testing
- InnAVasc arteriovenous graft surgical implant
- Where
- 7 sites in United States
- Volunteers
- 26 people
- Sponsor
- W.L.Gore & Associates
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.
Vascular Stent-Graft Stenosis
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study
This study will confirm the efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® stent graft (hereafter referred to as "Viabahn") for the treatment of patients with stenosis or occlusion at the…
- Trial name
- NCT04429243
- Testing
- GORE® VIABAHN® Stent Graft
- Where
- 17 sites in Japan
- Volunteers
- 124 people
- Sponsor
- W.L.Gore & Associates
End-Stage Renal Disease, End-Stage Kidney Disease
Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibody) in Participants With End Stage Renal Disease Receiving Hemodialysis (FXI Hemodialysis Study) (MK-2060-007)
The purpose of this study is to evaluate the efficacy and safety of two different doses of MK-2060 (a monoclonal antibody against Factor XI) in end stage renal disease (ESRD) participants receiving hemodialysis via an…
- Conditions
- End-Stage Renal Disease, End-Stage Kidney Disease, Kidney Failure, Chronic
- Trial name
- NCT05027074
- Testing
- MK-2060
- Where
- 120 sites in United States, Argentina and 13 more
- Volunteers
- 506 people
- Sponsor
- Merck Sharp & Dohme LLC
Restenosis
FLUENCY® PLUS Endovascular Stent Graft for In-stent Restenosis
The primary purpose of this study is to demonstrate that the FLUENCY® PLUS Endovascular Stent Graft can effectively and safely treat in-stent restenotic lesions in the venous outflow of the Arteriovenous (AV) access circuit of…
- Trial name
- RESCUE (NCT01257438)
- Testing
- Fluency Plus Endovascular Stent Graft, Percutaneous Transluminal Angioplasty only
- Where
- 23 sites in United States
- Volunteers
- 275 people
- Sponsor
- C. R. Bard
Arteriovenous Fistula, Arteriovenous Graft
Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients
This is a two stage, prospective, multi-center study to evaluate the EchoMark and EchoSure devices in patients undergoing peripheral arteriovenous fistula creation for hemodialysis access.
- Trial name
- NCT04017910
- Testing
- EchoMark/EchoSure
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Sonavex, Inc.
Arteriovenous Graft
An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Placement of an Arteriovenous Graft to Facilitate Hemodialysis Access
A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in extending the duration of primary patency after arteriovenous graft surgery in subjects with end-stage renal disease.
- Trial name
- NCT01806584
- Testing
- SRM003, Participating Site's standard practice
- Where
- 46 sites in United States
- Volunteers
- 32 people
- Sponsor
- Shire
Renal Failure, Hemodialysis
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
The objective of the study is to establish efficacy and safety of the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the…
- Trial name
- REVISE (NCT00737672)
- Testing
- GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface, Percutaneous Transluminal Angioplasty
- Where
- 31 sites in United States
- Volunteers
- 293 people
- Sponsor
- W.L.Gore & Associates
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.
End-stage Renal Disease
Propaten Randomized Investigation on Cost-benefit and Efficacy
The purpose for this study is to evaluate the patency and outcomes of conventional and heparin anticoagulant bonded arteriovenous grafts in patients with end stage renal disease.
- Trial name
- PRICE (NCT01601873)
- Testing
- PROPATEN, Standard Graft
- Where
- 5 sites in United States
- Volunteers
- 103 people
- Sponsor
- The University of Texas Health Science Center, Houston
End Stage Renal Disease
Clinical Evaluation of a Vascular Venous Anastomotic Connector [InterGraft VIG-only Study]
The InterGraft™ Venous Anastomotic Connector provides an endovascular, minimally invasive means for attachment of an arteriovenous graft to a vein in the upper extremity.
- Trial name
- NCT02532621
- Testing
- Venous InterGraft Connector, sutured arterial anastomosis of an implanted vascular graft for hemodialysis, hemodialysis
- Where
- 10 sites in United States
- Volunteers
- 158 people
- Sponsor
- Phraxis, Inc.
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 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.
Stenosis, Restenosis
Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the Arteriovenous (AV) access circuit.
- Trial name
- AVeNEW (NCT02649946)
- Testing
- Covera Vascular Covered Stent following PTA, Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon
- Where
- 24 sites in United States, Australia and 6 more
- Volunteers
- 280 people
- Sponsor
- C. R. Bard
Stenosis, Restenosis
Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft in AV Graft Patients (AVeVA)
The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the Arteriovenous (AV) access circuit.
- Trial name
- AVeVA (NCT02790606)
- Testing
- Covera(TM) Vascular Covered Stent
- Where
- 16 sites in United States
- Volunteers
- 110 people
- Sponsor
- C. R. Bard