Clinical trials: AVM
Arteriovenous Fistula
Early Feasibility of the Velocity™ Percutaneous PAVF System
An early feasibility study of the the initial safety and efficacy of the Velocity Percutaneous Arterio-Venous Fistula (pAVF) System when used to percutaneously create an arteriovenous fistula in patients with ESRD requiring…
- Trial name
- VENOS-1 (NCT05757726)
- Testing
- Velocity pAVF system
- Where
- Paraguay
- Volunteers
- 10 people
- Sponsor
- Venova Medical
Cerebral Arteriovenous Malformations
Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs
To assess safety and efficacy of ONYX treatment for cAVM:
- Trial name
- cAVM (NCT02180958)
- Where
- 17 sites in France
- Volunteers
- 140 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
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, 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 Malformations
Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study
The purpose of this study is to evaluate the safety of the Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain arteriovenous malformation (AVM) embolization procedures.
- Trial name
- NCT02378883
- Testing
- Apollo™ Onyx™ Delivery Micro Catheter
- Where
- 2 sites in United States
- Volunteers
- 112 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
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
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
Chronic Kidney Disease (CKD)
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction (IR)
The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) including coiling of the brachial vein during the…
- Trial name
- NCT02119832
- Testing
- Endovasccular AVF (EndoAVF)
- Where
- Paraguay
- Volunteers
- 17 people
- Sponsor
- C. R. Bard
Arteriovenous Fistula
ONYX Evaluation in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulae
The objective of this study is to evaluate the safety and performance post last embolization with Onyx
- Trial name
- dAVF (NCT02180945)
- Where
- France
- Volunteers
- 110 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
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 Malformation (AVM)
Post-Market Clinical Follow-up Study of i-ED Coil and EDG v4 for Arteriovenous Malformation
This is a prospective, multicenter, post-market clinical follow-up (PMCF) study to collect safety and performance data in patients with arteriovenous malformations (AVMs) who undergo endovascular coil embolization using the i-ED…
- Trial name
- NCT07687472
- Testing
- Endovascular Coil Embolization
- Volunteers
- 36 people
- Sponsor
- Kaneka Corporation
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.
Intracranial Aneurysm
Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil
The primary objective of this study is to gather post market data on the Penumbra SMART COIL® System (Smart System) in the treatment of intracranial aneurysms and other malformations.
- Trial name
- SMART (NCT02729740)
- Testing
- Penumbra Smart Coil, Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)
- Where
- 72 sites in United States, Canada
- Volunteers
- 995 people
- Sponsor
- Penumbra Inc.
Cerebral Arteriovenous Malformations
Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent
A non-interventional multicentric study for patients with a cerebral AVM for which endovascular treatment is indicated.
- Trial name
- NCT02602990
- Testing
- SQUID™
- Where
- 6 sites in Belgium, Germany
- Volunteers
- 50 people
- Sponsor
- Emboflu
Visceral Artery Aneurysms, Arteriovenous Malformations
Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System
The primary objective of this study is to gather post market data on the Penumbra Ruby Coil System in the treatment of visceral artery aneurysms and arteriovenous malformations.
- Trial name
- NCT02079818
- Testing
- Penumbra Ruby Coil System
- Where
- United States
- Sponsor
- Penumbra Inc.
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.
Arterio-Venous Fistula, Kidney Failure, Chronic
VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ
This is a prospective single arm study enrolling patients who are scheduled for creation of a new Brachiocephalic or Radiocephalic AV fistula.
- Conditions
- Arterio-Venous Fistula, Kidney Failure, Chronic, Kidney Diseases, Renal Failure Chronic
- Trial name
- VALUE (NCT03246984)
- Testing
- VasQ
- Where
- 11 sites in France, Germany and 2 more
- Volunteers
- 80 people
- Sponsor
- Laminate Medical Technologies
Brain Arteriovenous Malformation, Arteriovenous Fistula
The Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation
This study is designed as a prospective, multi-center, open-label, non-inferiority, randomized controlled clinical trial. The control device is Onyx Liquid Embolic System marketed by Micro Therapeutics Inc.
- Trial name
- PARTNER (NCT07314047)
- Testing
- liquid embolic agent
- Where
- China
- Volunteers
- 116 people
- Sponsor
- MicroPort NeuroTech Co., Ltd.
Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
First-In-Man Single Arm Prospective Study to assess the safety and efficacy of ULTRAVIOLET UHP PTA balloon.
- Trial name
- ULTRAVIOLETFIM (NCT07330817)
- Testing
- PTA balloon
- Where
- Italy
- Volunteers
- 35 people
- Sponsor
- Cardionovum GmbH
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