Clinical trials: Arteriovenous Graft
Peripheral Artery Disease, Arteriovenous Fistula Stenosis
FLEX Arteriovenous Access Registry
Evaluation of the FLEX Vessel Prep system combined with angioplasty in the treatment of arteriovenous access stenosis.
- Conditions
- Peripheral Artery Disease, Arteriovenous Fistula Stenosis, Arteriovenous Graft Stenosis
- Trial name
- NCT04070365
- Testing
- FLEX Vessel Prep System followed by angioplasty
- Where
- 10 sites in United States
- Volunteers
- 114 people
- Sponsor
- VentureMed Group Inc.
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
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.
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
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.
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
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 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
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
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.
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.
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
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.
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
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
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.
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
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
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 Access
Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use
Vascugel™ is safe when placed at the anastomotic site at the time of surgery during creation of an AV graft or fistula for hemodialysis access.
- Trial name
- NCT00479180
- Testing
- Vascugel
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Pervasis Therapeutics, Inc