Clinical trials: Vascular Malformations
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
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.
Chronic Kidney Diseases, Diabetes
KidneYou - Innovative Digital Therapy
The aim of the study is to assess the improvement of health in patients affected by CKD when they are exposed to non-pharmacological treatment strategies as nutritional program (NP), physical activity program (PA) and mindfulness…
- Conditions
- Chronic Kidney Diseases, Diabetes, Arterial Hypertension, Chronic Glomerulonephritis
- Trial name
- NCT05286632
- Testing
- KidneYou APP
- Where
- Italy
- Volunteers
- 210 people
- Sponsor
- Advice Pharma Group srl
Fistulas Arteriovenous
A Safety and Efficacy Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With DissolveAV
Drug-coated balloons delivering paclitaxel at the angioplasty site have proved their superiority in the treatment of coronary and peripheral arterial stenoses.
- Trial name
- DissolveAVF (NCT04226599)
- Testing
- Dissolve AVF, Armada 35
- Where
- 10 sites in China
- Volunteers
- 220 people
- Sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
Hereditary Hemorrhagic Telangiectasia
A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
The purpose of this study is to: evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-6400 in healthy volunteers evaluate the efficacy, safety, tolerability and PD of…
- Trial name
- InsigHHT (NCT06659640)
- Testing
- ALN-6400
- Where
- 16 sites in United States, Australia and 4 more
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Alnylam Pharmaceuticals
Benign Tumors, Malignant Tumors
Bioseal Dural Sealing Study BIOS-14-001
A Prospective, Randomized, Controlled, Single Blinded, Study to Evaluate the Safety and Effectiveness of Bioseal as an Adjunct to Sutured Dural Repair
- Conditions
- Benign Tumors, Malignant Tumors, Vascular Malformation
- Trial name
- NCT03110783
- Testing
- Bioseal
- Where
- 10 sites in China
- Volunteers
- 200 people
- Sponsor
- Guangzhou Bioseal Biotechnology Co., Ltd.
Stenosis, Bleed Intracranial
Beacon Tip Sizing Catheter and Slip-Cath Beacon Tip Catheter Study
This prospective observational post-market clinical study will collect data in the United States to primarily support the re-launch of the re-designed Beacon Tip Sizing Catheter and Slip-Catheter Beacon Tip Catheter \& Shuttle…
- Conditions
- Stenosis, Bleed Intracranial, Stroke, TIA
- Trial name
- NCT06986954
- Testing
- Beacon Tip Catheters
- Where
- United States
- Volunteers
- 816 people
- Sponsor
- Cook Research Incorporated
Chronic Kidney Disease Requiring Hemodialysis, End Stage Renal Disease (ESRD)
Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System for Creating Hemodialysis Vascular Access
The Velocity Percutaneous Arterio-Venous System is a minimally invasive method of creating hemodialysis vascular access. The study aims to understand clinical efficacy and initial clinical safety data of the device.
- Trial name
- VENOS-2 (NCT06712251)
- Testing
- Velocity pAVF System
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Venova Medical
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
Post Approval Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
The objective of this study is to collect post-market, real-world safety and effectiveness data of the COVERA Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous…
- Trial name
- NCT04261686
- Testing
- Covera Vascular Covered Stent
- Where
- 11 sites in United States
- Volunteers
- 100 people
- Sponsor
- C. R. Bard
Chronic Kidney Disease
A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients
PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel.
- Trial name
- NCT00679991
- Testing
- PRT-201
- Where
- 11 sites in United States
- Volunteers
- 66 people
- Sponsor
- Proteon Therapeutics
Epilepsy, Dravet Syndrome
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.
- Conditions
- Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
- Trial name
- ELEKTRA (NCT03650452)
- Testing
- TAK-935
- Where
- 44 sites in United States, Australia and 6 more
- Volunteers
- 141 people
- Sponsor
- Takeda
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
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, 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.
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
Intracranial Arteriovenous Malformations
Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations
The purpose of this study is to verify the efficacy and safety of the Liquid Embolic System (Tonbridge Medical Tech. Co., Ltd. (Suzhou)) for the treatment of cerebrovascular malformations.
- Trial name
- NCT06479343
- Testing
- Liquid Embolic System (Tonbridge), Onyx Liquid Embolic System (Medtronic)
- Where
- 14 sites in China
- Volunteers
- 170 people
- Sponsor
- Ton-Bridge Medical Tech. Co., Ltd
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
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.
Dural Arteriovenous Fistula
PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF
The primary objective of this study is to demonstrate the safety and efficacy of the PHIL® liquid in endovascular treatment of dural arteriovenous fistula.
- Trial name
- NCT03317821
- Where
- 16 sites in Denmark, France and 3 more
- Volunteers
- 70 people
- Sponsor
- Microvention-Terumo, Inc.