Clinical trials: AV Fistula
Complication of Renal Dialysis, End Stage Renal Disease
A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery
The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an…
- Conditions
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD
- Trial name
- ACCESS2 (NCT05425056)
- Testing
- Sirolimus
- Where
- 22 sites in United States, United Kingdom
- Volunteers
- 136 people
- Sponsor
- Vascular Therapies, Inc.
End Stage Renal Disease, AV Fistula
Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD
A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a less invasive means of establishing vascular access to facilitate dialysis in patients with end stage renal disease.
- Conditions
- End Stage Renal Disease, AV Fistula, Fistula, End Stage Kidney Disease
- Trial name
- NCT02363972
- Testing
- Ellipsys Vascular Access Catheter
- Where
- 5 sites in United States
- Volunteers
- 103 people
- Sponsor
- Medtronic Endovascular
Arteriovenous Fistula
Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae
This prospective, global, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Lutonix 035 AV Drug Coated Balloon PTA Catheter compared to a standard PTA Catheter in treating…
- Trial name
- NCT02440022
- Testing
- Lutonix DCB, Standard Balloon Angioplasty Catheter, Percutaneous Transluminal Angiography
- Where
- 23 sites in United States
- Volunteers
- 285 people
- Sponsor
- C. R. Bard
Arteriovenous Dural Fistula
PHIL in the Treatment of Intracranial dAVF.
This study is a prospective, multicenter, single-arm study. Patients with Dural Arteriovenous Fistulas (dAVF) have a few choice for safe treatment.
- Trial name
- PHIL dAVF (NCT03467542)
- Testing
- PHIL® Liquid Embolic System
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Microvention-Terumo, Inc.
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.
Chronic Kidney Disease
A Study of Vonapanitase (PRT-201) Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-2)
This research study is designed to assess the safety and effectiveness of an experimental drug called vonapanitase (PRT-201) in patients both receiving or expecting to receive hemodialysis who have chronic kidney disease and who…
- Trial name
- NCT02414841
- Testing
- Vonapanitase
- Where
- 41 sites in United States, Canada
- Volunteers
- 696 people
- Sponsor
- Proteon Therapeutics
Arterio-Venous Fistula, ESRD
VasQ External Support for Arteriovenous Fistula
This is a prospective clinical study of the VasQ external support for arteriovenous fistulas. The device is designed to improve fistula outcomes by optimizing the geometrical configuration of the fistula, influencing…
- Conditions
- Arterio-Venous Fistula, ESRD, Steal Syndrome, Aneurysm
- Trial name
- NCT03242343
- Testing
- VasQ
- Where
- 15 sites in United States
- Volunteers
- 144 people
- Sponsor
- Laminate Medical Technologies
End Stage Renal Disease, AV Fistula
Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae
The SAVE Study will evaluate the safety and efficacy of the Venous Window Needle Guide in achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis as prescribed.
- Conditions
- End Stage Renal Disease, AV Fistula, Kidney Failure
- Trial name
- SAVE (NCT01471041)
- Testing
- Venous Window Needle Guide
- Where
- 2 sites in United States
- Volunteers
- 54 people
- Sponsor
- Vital Access Corp.
Arteriovenous Fistula Stenosis
FLEX Vessel Prep Prior to Angioplasty in Native Arteriovenous Fistulae (AVF)
A prospective, multi-center, randomized observational post-market study evaluating the FLEX Vessel Prep device plus percutaneous angioplasty (PTA) vs PTA alone for the treatment of obstructive lesions in the native arteriovenous…
- Trial name
- NCT05034939
- Testing
- FLEX Vessel Prep System, Angioplasty
- Where
- 7 sites in United States
- Volunteers
- 75 people
- Sponsor
- VentureMed Group Inc.
Complication of Renal Dialysis, End Stage Renal Disease
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index…
- Conditions
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD
- Trial name
- ACCESS (NCT02513303)
- Testing
- Sirolimus, AV Fistula Surgery, Sirolimus-eluting Collagen Implant (SeCI)
- Where
- 4 sites in United States
- Volunteers
- 269 people
- Sponsor
- Vascular Therapies, Inc.
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 Fistula Stenosis, Arteriovenous Fistula Occlusion
IN.PACT™ AV Access IDE Study
To evaluate the safety and efficacy of the IN.PACT™ AV Access Drug Coated Balloon (DCB) compared to percutaneous transluminal angioplasty (PTA) for treatment of subjects presenting with de novo or non-stented restenotic…
- Conditions
- Arteriovenous Fistula Stenosis, Arteriovenous Fistula Occlusion, Arteriovenous Fistula, Fistula
- Trial name
- NCT03041467
- Testing
- IN.PACT AV DCB, Standard Balloon Angioplasty
- Where
- 29 sites in United States, Japan and 1 more
- Volunteers
- 330 people
- Sponsor
- Medtronic Endovascular
Renal Disease, End Stage, Kidney Disease, End-Stage
Ellipsys Vascular Access System Post Market Surveillance (PS) Study
The proposed clinical study is a prospective, non-randomized, multi-center, single-arm, observational, post-market surveillance (PS) study of the Ellipsys Vascular Access System in subjects eligible for arteriovenous (AV) fistula.
- Conditions
- Renal Disease, End Stage, Kidney Disease, End-Stage, AV Fistula, Fistulas Arteriovenous
- Trial name
- NCT04484220
- Testing
- Ellipsys Vascular Access System
- Where
- 12 sites in United States
- Volunteers
- 142 people
- Sponsor
- Medtronic Endovascular
Procedural Sedation
A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures.
Very often patients receive medications before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation.
- Trial name
- NCT00327392
- Testing
- AQUAVAN® (fospropofol disodium) Injection
- Where
- 15 sites in United States
- Volunteers
- 123 people
- Sponsor
- Eisai Inc.
Arteriovenous Fistula
An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access
A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in improving the rate of AVF maturation and use in subjects with end-stage renal disease undergoing surgery for creation…
- Trial name
- NCT01806545
- Testing
- SRM003, Participating Site's standard practice
- Where
- 47 sites in United States
- Volunteers
- 64 people
- Sponsor
- Shire
Kidney Diseases, Arteriovenous Fistula
Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae
Multi-center trial to assess the feasibility and safety of the EchoMark LP and the EchoMark diagnostic ultrasound system for assessing AV fistula blood flow, diameter, and depth.
- Trial name
- NCT04896476
- Testing
- EchoMark / EchoSure
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- Sonavex, 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
Critical Limb Ischemia, Chronic Limb-Threatening Ischemia
PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System
This pilot study will investigate the safety, effectiveness and feasibility of the LimFlow Stent Graft System for creating an AV fistula in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive…
- Trial name
- NCT03124875
- Testing
- LimFlow System
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- LimFlow, Inc.
End Stage Renal Disease
Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-Clinic Hemodialysis
This study is a prospective, multi-center, single-arm study with subjects acting as their own control designed to confirm the safety, performance, and usability of the V Needle, a new safety needle for use during in-clinic…
- Trial name
- Clinic-SAVER (NCT05493423)
- Testing
- V Needle AV Fistula Set
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Hemotek Medical Inc
Chronic Kidney Disease
A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)
This research study is designed to assess the safety and effectiveness of an experimental drug called PRT-201 in patients both receiving or expecting to receive dialysis who have chronic kidney disease and who are undergoing…
- Trial name
- NCT02110901
- Testing
- PRT-201
- Where
- 35 sites in United States
- Volunteers
- 349 people
- Sponsor
- Proteon Therapeutics