Clinical trials: Dysfunctional AV Fistula
Arteriovenous Fistula Renal Dialysis Devices Obstruction
Primary Patency in Post-angioplasty Dysfunctional Arteriovenous Fistula in Renal Dialysis: Paclitaxel-releasing PTA Balloon Catheter vs PTA Balloon
In recent years the use of paclitaxel releasing percutaneous transluminal angioplastic (PTA) balloon catheter is spreading in vascular pathology, mainly in stenosis infrainguinal arteries.
- Trial name
- FISBAL (NCT02565953)
- Testing
- Paclitaxel-releasing PTA balloon catheter, PTA balloon catheter
- Where
- 4 sites in Spain
- Volunteers
- 134 people
- Sponsor
- Fundación Pública Andaluza Progreso y Salud
Arteriovenous Fistula
Lutonix® Global AV Registry Investigating Lutonix Drug Coated Balloon for Treatment of Native and Synthetic AV Fistulae
The purpose of this Registry is to enroll patients presenting with clinical and hemodynamic abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm.
- Trial name
- AVR (NCT02746159)
- Testing
- Lutonix 035 Drug Coated Balloon PTA Catheter, Model 9004
- Where
- 26 sites in Austria, France and 11 more
- Volunteers
- 320 people
- Sponsor
- C. R. Bard
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
Arteriovenous Fistula
Study Evaluating the Safety and Efficacy of Tri-wire Balloon for Treatment of Dysfunctional AV Fistula
This prospective, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Tri-wire Peripheral Balloon Dilatation Catheter compared to a standard PTA Catheter in treating subjects…
- Trial name
- NCT04393688
- Testing
- Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter
- Where
- 7 sites in China
- Volunteers
- 168 people
- Sponsor
- BrosMed Medical Co., Ltd
Dialysis Access Malfunction, Stenosis
A Real-world Registry Investigating Sirolimus-coated Balloon Versus Paclitaxel-coated Balloon Angioplasty for the Treatment of Dysfunctional Arteriovenous Fistula
Drug-coated balloon (DCB) angioplasty has been shown to be superior to POBA in the treatment of stenosis in AVF. This is because the very intervention used to treat underlying stenosis by POBA can induce vascular injury and…
- Trial name
- SAVE AVF (NCT05333640)
- Testing
- Sirolimus Drug Coated Balloon, Paclitaxel Drug Coated Balloon
- Where
- Singapore
- Volunteers
- 200 people
- Sponsor
- Singapore General Hospital
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
AV Fistula
SAVE Trial - Use of the Selution Sirolimus Eluting Balloon for Dysfunctional AV accEss Treatment Indications
Prospective multi-center single-blinded randomized controlled trial (RCT) investigating the safety and feasibility of the SELUTION SLR™ (Sustained Limus Release) 018 drug eluting balloon (DEB) for the treatment of failed AV…
- Trial name
- SAVE (NCT04327609)
- Testing
- SELUTION SLR™ DEB, Control Arm
- Where
- 3 sites in Greece, Singapore
- Volunteers
- 84 people
- Sponsor
- M.A. Med Alliance S.A.
Dialysis Access Dysfunction, Endovascular Procedure
A Neuromodulation Auditory System to Optimize Patient Experience During Dysfunctional Dialysis Access Endovascular Procedures
Peri-procedural stress is a common challenge in interventional radiology that can negatively impact patient tolerance and the overall procedural experience.
- Conditions
- Dialysis Access Dysfunction, Endovascular Procedure, Patient Experience, Neuromodulation
- Trial name
- NCT07467642
- Testing
- Neuromodulation auditory system
- Where
- 2 sites in Greece
- Volunteers
- 100 people
- Sponsor
- Attikon Hospital
Peripheral Artery Disease (PAD), Dysfunctional AV Fistula
Serranator POINT FORCE Registry
The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® in treatment of peripheral artery disease (PAD), or dysfunctional native or…
- Conditions
- Peripheral Artery Disease (PAD), Dysfunctional AV Fistula, Dysfunctional AV Graft
- Trial name
- POINT FORCE (NCT06687590)
- Testing
- Peripheral balloon angioplasty
- Where
- 19 sites in United States
- Volunteers
- 500 people
- Sponsor
- Cagent Vascular LLC
Arteriovenous Fistula
Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae
This prospective, global, multicenter, single arm post-approval study is designed to investigate the clinical use and safety of the Lutonix® 035 AV Drug Coated Balloon (DCB) PTA Catheter in subjects presenting with clinical and…
- Trial name
- AVPAS (NCT03506308)
- Testing
- LUTONIX 035 Drug Coated Balloon PTA Catheter
- Where
- 26 sites in United States, Canada
- Volunteers
- 213 people
- Sponsor
- C. R. Bard
Dialysis Access Malfunction
Volume Flow Assessment to Optimize Angioplasty of Dysfunctional Dialysis Access
This is a multicenter, prospective study investigating a new concept of intra-procedural percutaneous duplex ultrasound (DUS) volume flow-guided balloon angioplasty for the quantification and optimization of endovascular…
- Trial name
- VOLAII (NCT04694287)
- Testing
- Percutaneous DUS volume flow measurements
- Where
- 3 sites in Greece
- Volunteers
- 100 people
- Sponsor
- Attikon Hospital
Dialysis Access Malfunction
Volume Flow-guided Angioplasty of Dysfunctional Dialysis Access
This is a pilot study investigating a new concept of intra-procedural percutaneous duplex ultrasound (DUS) volume flow-guided balloon angioplasty for the quantification and optimization of endovascular treatment outcomes of…
- Trial name
- VOLA (NCT04430478)
- Testing
- Volume flow guided angioplasty
- Where
- 3 sites in Greece
- Volunteers
- 20 people
- Sponsor
- Attikon Hospital
Dysfunctional Dialysis Arteriovenous Fistula
Drug Coated Balloons vs Plain Balloons for the Management of Dysfunctional Dialysis Fistula
Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis arteriovenous fistulas (AVFs).
- Trial name
- NCT03189667
- Testing
- Vessel preparation with angioplasty, Plain balloon angioplasty, Drug coated balloon angioplasty
- Where
- Saudi Arabia
- Volunteers
- 23 people
- Sponsor
- King Abdullah International Medical Research Center