Clinical trials: Dysfunctional AV Fistula
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
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.
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