Clinical trials: Arteriovenous Graft
End Stage Renal Disease
A Pilot Study To Evaluate The CreatiVasc Hemoaccess Valve System In Patients Requiring Arteriovenous Graft Placement
The ability to selectively control blood flow through an arteriovenous (AV) graft only when it is needed for dialysis may reduce the current repetitive complications such as thrombosis, venous hypertension post-dialysis bleeding…
- Trial name
- NCT01644526
- Testing
- Hemoaccess Valve System
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Diaxamed LLC
Venous Stenosis, Venous Occlusion
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
The WRAP Study aims to expand and understand the safety and efficacy data on the WRAPSODY Endoprosthesis System in a real-world population.
- Trial name
- NCT05062291
- Testing
- Merit WRAPSODY Endovascular Stent Graft
- Where
- 35 sites in Australia, Brazil and 7 more
- Volunteers
- 500 people
- Sponsor
- Merit Medical Systems, Inc.
Diseased or Occluded Blood Vessels, Arteriovenous Shunting for Blood Access
LeMaitre LifeSpan® ePTFE Vascular Graft Retrospective Registry
This is a post-market, single-arm, retrospective registry. The investigator or its representative will identify eligible patients through a medical record search.
- Trial name
- NCT04620889
- Testing
- AV Access, PVP
- Where
- Germany
- Volunteers
- 153 people
- Sponsor
- LeMaitre Vascular
Arteriovenous Fistula
Post Approval Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
The objective of this study is to collect post-market, real-world safety and effectiveness data of the COVERA Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous…
- Trial name
- NCT04261686
- Testing
- Covera Vascular Covered Stent
- Where
- 11 sites in United States
- Volunteers
- 100 people
- Sponsor
- C. R. Bard
Venous Stenosis, Venous Occlusion
WRAP North America
The goal of this observational study is to investigate the safety and efficacy of the WRAPSODY CIE in a real-world North American population.
- Trial name
- NCT06807099
- Testing
- Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)
- Where
- 16 sites in United States, Canada
- Volunteers
- 250 people
- Sponsor
- Merit Medical Systems, Inc.
THROMBOSED AV GRAFTS
Pilot Study of IVUS Imaging During Endovascular Interventions of Failing Hemodialysis Access Grafts
This pilot study will provide data to aid in the planning of a follow-up multi-center randomized, controlled trial (RCT). As such, the sample size for this pilot is not driven by formal statistical hypothesis testing.
- Trial name
- NCT01929369
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Volcano Corporation
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
Needle Phobia, Phobic Disorders
Effect of Including Synera® in Discussions on Dialysis Access Conversion in Patients With Needle Phobias
An arteriovenous fistula or graft access (AVF/AVG) for dialysis is often considered a superior option for delivery of dialysis, but requires needles to be inserted.
- Trial name
- NCT01623583
- Testing
- Enhanced Needle Phobia Intervention, Standard Needle Phobia Intervention
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Davita Clinical Research
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
End Stage Renal Disease (ESRD)
EndoForce Post Approval Study
The goal of this observational study is to collect long-term safety and performance data for the use of the EndoForce System for connecting a hemodialysis graft to a vein in patients with End Stage Renal Disease.
- Trial name
- NCT07146854
- Where
- 2 sites in United States
- Volunteers
- 150 people
- Sponsor
- Phraxis, Inc.
Chronic Kidney Disease
A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease
PRT-201 is a recombinant human type-I pancreatic elastase intended for local, long-lasting dilation of the AVG venous anastomosis and outflow vein.
- Trial name
- PRT-201-102 (NCT01001351)
- Testing
- PRT-201
- Where
- 16 sites in United States
- Volunteers
- 89 people
- Sponsor
- Proteon Therapeutics
ESRD, Hemodialysis
Use of a Lifeline Graft in the A-V Shunt Model
This study will assess the safety and efficacy of a completely autologous and completely biological tissue engineered blood vessel (TEBV) called Lifeline™ used as an arteriovenous fistula for dialysis access.
- Trial name
- NCT00850252
- Testing
- Lifeline
- Where
- 2 sites in Argentina, Poland
- Sponsor
- Cytograft Tissue Engineering
Arteriovenous Fistula, Arteriovenous Graft
FLEX FIRST Registry Research Protocol
Prospective, observational study evaluating the clinical use and outcomes of the FLEX Vessel Prep (VP) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities following 12 months post…
- Conditions
- Arteriovenous Fistula, Arteriovenous Graft, Fistula, Arterial Occlusive Diseases
- Trial name
- NCT05616104
- Testing
- FLEX Vessel Prep System
- Where
- 4 sites in United States
- Volunteers
- 130 people
- Sponsor
- VentureMed Group Inc.
Arteriovenous Graft Stenosis
Scoring Balloon and High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis
This is a multicenter, prospective, randomized controlled clinical study. Patients with hemodialysis arteriovenous graft fistula stenosis will be recruited to explore whether the scoring balloon is superior to the high pressure…
- Trial name
- DKTAVG (NCT06503692)
- Testing
- DKutting PTA Scoring Balloon Dilatation Catheter, Peripheral Balloon Catheter
- Where
- 7 sites in China, Singapore
- Volunteers
- 140 people
- Sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
Arteriovenous Graft Thrombosis
AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System
A prospective, single-arm, non-blinded study, intending to treat and collect and evaluate data in up to ten (10) human subjects who are currently being treated with hemodialysis and who present with acute thrombosis in their…
- Trial name
- AVATR (NCT04494035)
- Testing
- CAPERE Thrombectomy System
- Where
- Canada
- Volunteers
- 7 people
- Sponsor
- Medtronic Endovascular
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.
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
Dysfunctional AV Graft, Dysfunctional AV Fistula
Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts
The purpose of this study is to evaluate the Lutonix® 035 Drug Coated Balloon PTA Catheter (CE mark) for use as intended in the treatment of subjects with clinically significant hemodialysis vascular access stenosis or occlusion.
- Trial name
- ACCESS (NCT02183194)
- Testing
- Lutonix Paclitaxel Drug Coated Balloon
- Where
- 4 sites in Austria, Germany
- Sponsor
- C. R. Bard
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
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.