Clinical trials: Unruptured Intracranial Aneurysm
Ruptured and Unruptured Intracranial Aneurysms
Mid-term Data Collection of the Treatment of Intracranial Aneurysms With the WEB™ Aneurysm Embolization System
Flow disruption is a new endovascular approach for treatment of both ruptured and unruptured intracranial aneurysms, which involves placement of an endosaccular device (WEB) which modifies the blood flow at the level of the neck…
- Trial name
- NCT03379714
- Testing
- WEB aneurysm embolization system
- Where
- Belgium
- Sponsor
- Medical Therapy Solutions
Aneurysm, Intracranial
China Surpass Streamline Post-Market Study
A multi-center, prospective, single-arm, non-randomized, post-market, observational study. The primary objective of this study is to evaluate the long-term safety and efficacy of the Surpass Streamline Flow Diverter System (FDS)…
- Trial name
- NCT05544045
- Testing
- Surpass Streamline Flow Diverter System
- Where
- 15 sites in China
- Volunteers
- 11 people
- Sponsor
- Stryker Neurovascular
Aneurysm Cerebral
Study to Evaluate the TUBE Device Ability to Treat Unruptured, Wide-neck or Fusiform Aneurysms
To assess the safety and performance of the TUBE device in the endovascular treatment of unruptured, wide-neck or fusiform intracranial aneurysms located on the internal carotid artery (ICA) or its branches
- Trial name
- NV01 (NCT07079956)
- Testing
- TUBE Flow Diverter
- Where
- 3 sites in Brazil
- Volunteers
- 20 people
- Sponsor
- NVMedTech
Intracranial Saccular Aneurysm, Either Rupture or Unruptured, Wide Neck Aneurysm
Solitaire Aneurysm Remodeling Registry
The objective of the registry is to evaluate the effectiveness and performance of the Solitaire Neurovascular Remodeling Device when used with embolic coils in the treatment of intracranial aneurysms.
- Trial name
- NCT04905303
- Where
- France
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Unruptured Intracranial Aneurysm
Assessment of the Clinical and Economic Impact of Sim&Size, a Simulation Software for Implantable Devices Used in the Treatment of Intracranial Aneurysms: A Prospective Multicenter Study.
In recent years, endovascular treatment of intracranial aneurysms has seen remarkable growth, now surpassing traditional surgical approaches in terms of frequency of use.
- Trial name
- ESSNAI (NCT07433075)
- Testing
- 3D simulation of placement of neurovascular implantable medical device, Manual planning of endovascular procedure
- Where
- 6 sites in France
- Volunteers
- 576 people
- Sponsor
- Sim&Cure
Aneurysm, Intracranial Aneurysm
Appraising the Embolization of Aneurysms Using Balt Optima™ Coil System (APPLY Study)
In recent years, many developments have been made to the tools and techniques used to treat IAs via endovascular intervention. Specifically, to the detachable coils themselves.
- Conditions
- Aneurysm, Intracranial Aneurysm, Ruptured Aneurysm, Subarachnoid Hemorrhage, Aneurysmal
- Trial name
- APPLY (NCT04499508)
- Testing
- Optima Coil System
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Vascular Neurology of Southern California Inc.
Cerebral Aneurysm, Cerebral Aneurysm Unruptured
Parent Artery Reconstruction for Cerebral Aneurysms Using a Novel Flow Diverter With Surface Modification
The primary objective of this trial is to evaluate the safety and efficacy of the cerebral flow diverter in the endovascular treatment of wide-necked cerebral aneurysms
- Trial name
- NCT05774782
- Testing
- Cerebral flow diverter
- Where
- China
- Volunteers
- 143 people
- Sponsor
- Sinomed Neurovita Technology Inc.
Intracranial Aneurysm
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
The purpose of this study is to assess how safe choydar flow-directed mesh stent is and how well it works in the treatment of unruptured intracranial aneurysms (a condition in which a bulging blood vessel in the brain can burst…
- Trial name
- CROWN (NCT07228312)
- Where
- 8 sites in China
- Volunteers
- 200 people
- Sponsor
- Johnson & Johnson Medical (Shanghai) Ltd.
Intracranial Aneurysm
Pivotal Study of the Silk Vista Baby Flow Diverters in the Treatment of Unruptured Intracranial Aneurysms (PIONEER)
The PIONEER Study is a pivotal, multi-center, prospective, single-arm study designed to evaluate the safety and efficacy of the Silk Vista Baby (SVB) Flow Diverter for the treatment of unruptured aneurysms.
- Trial name
- PIONEER (NCT07225075)
- Testing
- Silk Vista Baby (SVB) Flow Diverter
- Where
- 6 sites in United States, Canada
- Volunteers
- 250 people
- Sponsor
- Balt USA
Aneurysm Cerebral, Bifurcation
LUMENS-1 EU EFS CIP
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
- NCT06761365
- Testing
- LuSeed Aneurysm Embolization System
- Where
- 6 sites in Bulgaria, Germany and 2 more
- Volunteers
- 30 people
- Sponsor
- LuSeed Vascular LTD.
Ruptured and Unruptured Intracranial Aneurysms
Mid-term Data Collection of the Treatment of Intracranial Aneurysms With the WEB™ Aneurysm Embolization System
Flow disruption is a new endovascular approach for treatment of both ruptured and unruptured intracranial aneurysms, which involves placement of an endosaccular device (WEB) which modifies the blood flow at the level of the neck…
- Trial name
- NCT03312725
- Testing
- WEB aneurysm embolization system
- Where
- Belgium
- Volunteers
- 1 people
- Sponsor
- Medical Therapy Solutions
Cerebral Aneurysm
A Medical Device to Treat Brain Aneurysms
An aneurysm is a bulge in a blood vessel caused by a weakness in the blood vessel wall, usually where it branches. As blood passes through the weakened blood vessel, the blood pressure causes a small area to bulge outwards like a…
- Trial name
- NCT04963933
- Testing
- Nautilus endovascular device
- Where
- 2 sites in Bulgaria, Latvia
- Volunteers
- 30 people
- Sponsor
- EndoStream Medical
Aneurysm Cerebral (Unruptured)
Multimodal Approach Feasability Study for Untreated and Unruptured Intracranial Aneurysms
This feasibility study aims to evaluate the SYLVER system's ability to visualize intracranial aneurysms in accordance with 3D rotational angiography (3DRA) as the reference technique.
- Trial name
- miniCAN (NCT07864389)
- Testing
- 3D CEUS
- Where
- France
- Volunteers
- 15 people
- Sponsor
- Resolve Stroke
Intracranial Aneurysm
Contour Neurovascular System - European Pre-Market Unruptured Aneurysm
Cerus Endovascular is sponsoring a prospective, multi-center trial to document the safety and performance of the Contour Neurovascular System™ ("Contour").
- Trial name
- CERUS (NCT03680742)
- Testing
- Contour Neurovascular System
- Where
- 6 sites in Austria, Denmark and 1 more
- Volunteers
- 34 people
- Sponsor
- Cerus Endovascular, Inc.
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
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.
Intracranial Aneurysm
pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2
To assess safety and efficacy of pCONUS2 for the treatment of wide neck bifurcation aneurysms.
- Trial name
- pToWin2 (NCT03273478)
- Testing
- Endovascular treatment of bifurcation aneurysm with pCONUS2
- Volunteers
- 100 people
- Sponsor
- Phenox GmbH
Intracranial Aneurysm, Stroke, Ischemic
Neurovascular Product Surveillance Registry
Post market surveillance registry
- Trial name
- INSPIRE (NCT02988128)
- Testing
- Treatment for intracranial aneurysms, Treatment for Acute Ischemic Stroke
- Where
- 99 sites in Argentina, Australia and 22 more
- Volunteers
- 4,000 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Hemorrhagic Stroke, Aneurysm, Intracranial
The Use of p48/64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms
To determine safety and effectiveness of the p48 MW HPC and p64 MW HPC Flow Modulation Device in the treatment of wide-necked intracranial aneurysms.
- Conditions
- Hemorrhagic Stroke, Aneurysm, Intracranial, Saccular Aneurysm, Fusiform Aneurysm
- Trial name
- PIANO (NCT07143019)
- Testing
- Flow diversion
- Where
- 25 sites in United States
- Volunteers
- 214 people
- Sponsor
- phenox Inc.
Aneurysm, Aneurysm, Intracranial
Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD)
The objective of the Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms with Surpass Elite with GUARDian Flow Diverter (GUARD) trial is to evaluate the safety and efficacy of the Surpass Elite with Guardian…
- Trial name
- GUARD (NCT06872684)
- Testing
- Surpass Elite with Guardian Flow Diverter System
- Where
- 20 sites in United States
- Volunteers
- 183 people
- Sponsor
- Stryker Neurovascular