Clinical trials: Cerebral Aneurysm
Aneurysm, Brain
Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities
The objective of this study is to demonstrate the safety and efficacy of the Penumbra SMART COIL® System, including the WAVE™ Extra Soft Coils (WAVE) as a fill and finish coil, in the treatment of intracranial aneurysms.
- Trial name
- SURF (NCT04106583)
- Testing
- WAVE, as part of the SMART COIL System
- Where
- 43 sites in United States, Canada and 4 more
- Volunteers
- 572 people
- Sponsor
- Penumbra Inc.
Intracranial Aneurysms
Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques
To date the standard non-surgical treatment strategy for treating un-ruptured intracranial aneurysms is the use of either coils or self-expandable stents.
- Trial name
- NCT01084681
- Testing
- Endovascular treatment of intracranial aneurysms, Endovascular treatment of intracranial aneurysm with coils
- Where
- Germany
- Volunteers
- 160 people
- Sponsor
- Balt International
Wide Neck Bifurcation Intracranial Aneurysms, Intracranial Aneurysms
The WEB-IT Clinical Study
The study is a prospective, multicenter single-arm cohort. Patients with wide neck bifurcation aneurysms (WNBAs) have few choices for safe and effective endovascular treatment.
- Trial name
- WEB-IT (NCT02191618)
- Testing
- WEB
- Where
- 32 sites in United States, Canada and 4 more
- Volunteers
- 150 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysm
CATCH [Short Name for: Coil Application Trial in China]
The scope of this trial is the collection and analysis of effectiveness and safety endpoints, related to the use of the MicroPort NeuroTech Coil Embolization System in the treatment of intracranial aneurysms.
- Trial name
- CATCH (NCT02990156)
- Testing
- Coil Embolization System, Cotrol device from Medronic
- Where
- China
- Volunteers
- 334 people
- Sponsor
- MicroPort NeuroTech Co., Ltd.
Intracranial Aneurysm
Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device
The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device in the treatment of unruptured, wide-neck intracranial aneurysms.
- Trial name
- PREMIER (NCT02186561)
- Testing
- Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device
- Where
- 23 sites in United States, Canada
- Volunteers
- 197 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
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
Intracranial Aneurysm, Aneurysm
Coated Mongolian Aneurysm Treatment Study 1
The purpose of this study is to assess safety and effectiveness of the p64 MW HPC or p48 MW HPC Flow Modulation Device under Dual Antiplatelet Medication.
- Conditions
- Intracranial Aneurysm, Aneurysm, Vascular Diseases
- Trial name
- COMATS 1 (NCT04305626)
- Testing
- Endovascular treatment of intracranial aneurysms
- Where
- Mongolia
- Volunteers
- 90 people
- Sponsor
- Phenox GmbH
Intracranial Aneurysm
LVIS™ Evo™ and HydroCoil® Embolic System for Intracranial Aneurysm Treatment
This is a prospective multicenter international single-arm observational study to demonstrate that use of stent-assisted coiling with LVIS™ Evo™ and HydroCoil® Embolic System (HES) in intracranial aneurysm treatment is effective…
- Trial name
- SEALANT (NCT04999423)
- Testing
- LVIS EVO and HydroCoil Embolic System
- Where
- 19 sites in Belgium, France and 3 more
- Volunteers
- 206 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysm
Pipeline for Uncoilable or Failed Aneurysms
To determine the safety and effectiveness of Pipeline Embolization Device for the treatment of uncoilable or failed wide-necked intracranial aneurysms (IA).
- Trial name
- PUFS (NCT00777088)
- Testing
- Pipeline Embolization Device (PED)
- Where
- 10 sites in United States, Hungary and 1 more
- Volunteers
- 108 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
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
Saccular Aneurysm, Intracranial Aneurysm
European eCLIPS™ Safety, Feasibility and Efficacy Study
An open label, prospective, multicentre, single-arm, post marketing study evaluating the safety, technical feasibility, and efficacy of the eCLIPs™ Family of Products for the treatment of bifurcation intracranial aneurysms.
- Trial name
- EESIS (NCT02607501)
- Testing
- Implant eCLIPs
- Where
- 4 sites in Denmark, Germany and 1 more
- Volunteers
- 20 people
- Sponsor
- Evasc Medical Systems Corp.
Wide-neck, Saccular Intracranial Aneurysms
The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms
To assess the safety and effectiveness of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA).
- Trial name
- NCT01636453
- Testing
- Stent assisted coiling with the Liberty Stent
- Where
- 3 sites in United States
- Volunteers
- 120 people
- Sponsor
- Penumbra Inc.
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
Intracranial Aneurysm, Brain Arterial Disease
Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform
BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices.
- Conditions
- Intracranial Aneurysm, Brain Arterial Disease, Acute Ischemic Stroke, Peripheral Vascular Diseases
- Trial name
- EVIDENCE (NCT04927156)
- Testing
- BALT medical devices
- Where
- 12 sites in France, Germany and 1 more
- Volunteers
- 10,000 people
- Sponsor
- Balt Extrusion
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
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, 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
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
Evaluation of Safety and Efficacy of the Accero® (Heal) Stent for Intracranial Aneurysm Treatment
This study is intended to show that the application of the Accero® (heal) stent is safe within the given indication.
- Trial name
- NCT03957382
- Testing
- Accero® (heal) Stent
- Where
- 4 sites in Germany
- Volunteers
- 130 people
- Sponsor
- Acandis 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.