Clinical trials: Cerebral Aneurysm
Intracranial Aneurysm
Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy
This is a prospective, single-arm, multi-center post-market observational study assessing the performance of the Pipeline™ Flex Embolization Device with Shield Technology™ in subjects undergoing treatment for intracranial…
- Trial name
- SHIELD (NCT02719522)
- Testing
- Pipeline™ Flex Embolization Device with Shield Technology™
- Where
- 21 sites in Australia, Denmark and 9 more
- Volunteers
- 205 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Aortic Aneurysm, Aortic Dissection
Clinical Investigation of Clinical Safety and Performance of the SP-GRIPFLOW, Selective Cerebral Perfusion Catheter When Used for Cerebral Perfusion During Aortic Arch Repair
The purpose of this study is to determine if the SP-GRIPFLOW catheter (the catheter designed by Fuji Systems) is safe and how well it functions.
- Conditions
- Aortic Aneurysm, Aortic Dissection, Aortic Arch Aneurysm, Aortic Arch; Aneurysm, Dissecting
- Trial name
- NCT05421130
- Testing
- Selective Cerebral Perfusion Catheter
- Where
- 5 sites in Germany, Netherlands
- Volunteers
- 149 people
- Sponsor
- Fuji Systems Corporation
Intracranial Aneurysm
Tubridge Flow Diverter Study For Intracranial Aneurysms
The scope of this trial is the collection and analysis of the important safety outcomes in the real world, related to the use of the Tubridge flow diverter in the treatment of intracranial aneurysms.
- Trial name
- TRACE-IA (NCT05646108)
- Testing
- Endovascular treatment
- Where
- China
- Volunteers
- 5,000 people
- Sponsor
- MicroPort NeuroTech Co., Ltd.
Intracranial Aneurysm, Ruptured Aneurysm
EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization Device With Shield TEchnology™ (ELEVATE)
The purpose of the study is to assess the safety and effectiveness of the Pipeline™ Flex Embolization Device with Shield Technology™ in the treatment with acutely ruptured intracranial aneurysms.
- Trial name
- ELEVATE (NCT04391803)
- Testing
- Pipeline™ Flex Embolization Device with Shield Technology™
- Where
- 7 sites in United States
- Volunteers
- 25 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Unruptured Wide-neck Intracranial Aneurysms
A Study Evaluating the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm
This is a prospective, multi-center, non-randomized clinical evaluation utilizing the PulseRider® Aneurysm Neck Reconstruction Device.
- Trial name
- NAPA (NCT03383666)
- Testing
- PulseRider® Aneurysm Neck Reconstruction Device
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Pulsar Vascular
Intracranial Aneurysm
Post-Market Clinical Follow-Up Study to Confirm Clinical Performance and Safety of the Codman Enterprise® 2 Vascular Reconstruction Device in the Endovascular Treatment of Intracranial Aneurysms
The objective of this Post-Market Clinical Follow-up (PMCF) is to confirm the performance and safety of the Codman Enterprise® 2 when used in conjunction with endovascular coil embolization of ruptured or non-ruptured…
- Trial name
- SUNRISE-2 (NCT02415010)
- Testing
- Enterprise 2 Vascular Reconstruction Device
- Where
- 10 sites in Germany, Spain and 2 more
- Volunteers
- 26 people
- Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
Aneurysm Cerebral, Bifurcation
LUMENS-1 Canada Early Feasibility Study Clinical Investigation Plan
The primary objective of this clinical investigation is to evaluate the early safety and feasibility of the LuSeed Aneurysm Embolization System for treating unruptured intracranial aneurysms (IA).
- Conditions
- Aneurysm Cerebral, Bifurcation, Unruptured Intracranial Aneurysm, Saccular Aneurysm
- Trial name
- NCT07259018
- Testing
- LuSeed Aneurysm Embolization System
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- LuSeed Vascular LTD.
Subarachnoid Hemorrhage, Aneurysmal
Study of EG-1962 Compared to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage
This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid hemorrhage.
- Trial name
- NEWTON2 (NCT02790632)
- Testing
- EG-1962 (nimodipine microparticles), Enteral Nimodipine
- Where
- 79 sites in United States, Australia and 9 more
- Volunteers
- 374 people
- Sponsor
- Edge Therapeutics Inc
Brain Aneurysms
International Retrospective Study of Pipeline Embolization Device
The primary objective of this retrospective study is to determine the incidence of important safety outcomes in patients who have undergone Pipeline Embolization Device placement for intracranial aneurysms (IAs).
- Trial name
- IntrePED (NCT01558102)
- Where
- 17 sites in United States, Argentina and 4 more
- Volunteers
- 793 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Intracranial Aneurysm
WEB Clinical Assessment of IntraSaccular Aneurysm Therapy
The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm Embolization System used to embolize intracranial aneurysms
- Trial name
- WEBCAST (NCT01778322)
- Testing
- Intracranial aneurysm embolization
- Where
- 12 sites in Denmark, France and 2 more
- Volunteers
- 51 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysm
Complete Occlusion of Coilable Aneurysms
To compare the safety and effectiveness of Pipeline Embolization Device to coil embolization for the treatment of coilable wide-necked intracranial aneurysms
- Trial name
- COCOA (NCT00777907)
- Testing
- Pipeline Embolization Device (PED), Coil embolization
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- Chestnut Medical Technologies
Intracranial Aneurysm, Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion
Microvention AnEurysm & STroke Real-life Data cOllection
The MAESTRO registry is a post-market, single-arm, non-interventional, multicenter registry
- Conditions
- Intracranial Aneurysm, Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion, Aneurysmal Subarachnoid Hemorrhage, Ischemic Stroke
- Trial name
- MAESTRO (NCT06494436)
- Testing
- All Microvention Class III implantable device CE marked, All Microvention Mechanical Thrombectomy Class III device CE marked
- Where
- Spain
- Volunteers
- 1,000 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysm
Safety & Performance of the World Medica World Diverter Embolization Device
The objective of this study is to investgiate the safety and clinical performance of the World Diverter Emoblization Device for the endovascular treatment of wide-neck (neck width ≥ 4 mm or dome-to-neck ratio <2) or fusiform…
- Trial name
- NCT07339358
- Testing
- Flow diverter implantation
- Where
- Spain
- Volunteers
- 72 people
- Sponsor
- World Medica USA, LLC
Intracranial Aneurysm
Post Market Clinical Follow-up (PMCF)Study of the Contour Neurovascular SystemTM
Cerus Endovascular is sponsoring a prospective, multi-center PMCF to document the safety and performance of the Contour Neurovascular System™ (hereinafter "Contour") in normal medical use.
- Trial name
- NCT04579081
- Testing
- Contour Neurovascular System
- Sponsor
- Cerus Endovascular, Inc.
Aneurysm, Intracranial
An EFS Assessing the Electrolytic eCLIPs System for Treatment of Intracranial Aneurysms
The purpose of this study is to investigate the feasibility and initial clinical safety of eCLIPs device use for the treatment of wide-necked bifurcation aneurysms.
- Trial name
- NCT04886505
- Testing
- Electrolytic eCLIPs Bifurcation System
- Sponsor
- Evasc Medical Systems Corp.
Unruptured Cerebral Aneurysm
NEUROvascular NAVigation With Remotely Controlled Deflectable Guidewire, Study I (NeuroNAV Study I)
The aim of the study is to confirm the safe and successful use of the SmartGUIDE guidewire, when used in neuro interventions. The performance of the SmartGUIDE guidewire in terms of safe and successful navigation within the…
- Trial name
- NCT06972953
- Testing
- SmartGUIDE (deflectable guidewire), Any standard of care guidewire
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Artiria Medical
Intracranial Aneurysm
NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study
The purpose of the Pipeline™ Vantage Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Vantage PAS") is to collect safety and effectiveness data in patients undergoing treatment for intracranial…
- Trial name
- NCT06604884
- Testing
- Treatment of Intracranial Aneurysms
- Where
- 10 sites in United States
- Volunteers
- 118 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Intracranial Aneurysm, Aneurysm
Coated Mongolian Aneurysm Treatment Study 2
The purpose of this study is to assess safety and effectiveness of the p64 MW HPC or p48 MW HPC Flow Modulation Device under prasugrel.
- Conditions
- Intracranial Aneurysm, Aneurysm, Vascular Diseases
- Trial name
- COMATS 2 (NCT04305704)
- Where
- Mongolia
- Volunteers
- 90 people
- Sponsor
- Phenox GmbH
Intracranial Aneurysms
Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms
The purpose of this study is to evaluate the safety and effectiveness of the MicroVention Flow Redirection Intraluminal Device (FRED) system when used in the treatment of wide-necked intracranial aneurysms.
- Trial name
- FRED (NCT01801007)
- Testing
- Flow Re-Direction Endoluminal Device (FRED)
- Where
- 24 sites in United States, Japan
- Volunteers
- 145 people
- Sponsor
- Microvention-Terumo, Inc.
Aneurysms, Vascular Diseases
Researching AXIUM Coiling Experience and Recanalization (RACER)
The data collected in this study will be used to support International Regulatory submissions. The study objective is to evaluate the continued safety and efficacy of the AXIUM Progressive Coil System.
- Conditions
- Aneurysms, Vascular Diseases, Cerebrovascular Disorders, Intracranial Arterial Diseases
- Trial name
- RACER (NCT00703794)
- Testing
- The AXIUM Progressive Coil System
- Where
- 18 sites in United States
- Volunteers
- 119 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs