Clinical trials: Intracranial Aneurysm
Intracranial Aneurysms
MAPS Trial: Matrix And Platinum Science
Primary Objectives: To establish Target Aneurysm Recurrence (TAR) rates for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular aneurysms.
- Trial name
- MAPS (NCT00396981)
- Testing
- Matrix 2® coils for endovascular aneurysm occlusion, GDC® coils for endovascular aneurysm occlusion
- Where
- 43 sites in United States, Australia and 9 more
- Volunteers
- 626 people
- Sponsor
- Stryker Neurovascular
Wide Neck Intracranial Aneurysms
Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial Aneurysms
The purpose of this study is to assess the safety and performance of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms.
- Trial name
- NCT01753388
- Testing
- Liberty Stent
- Where
- 4 sites in Germany
- Sponsor
- Penumbra Inc.
Intracranial Aneurysm
Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation
To assess safety and efficacy of p64 MW HPC Flow Modulation Device under single antiplatelet therapy compared to p64 MW Flow Modulation Device under dual antiplatelet therapy.
- Trial name
- COATING (NCT04870047)
- Testing
- Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device
- Where
- 18 sites in France, Germany and 5 more
- Volunteers
- 171 people
- Sponsor
- Phenox GmbH
Saccular and Fusiform Aneurysms, Pseudoaneurysm
Targeting Real World Usage In Stroke Treatment
TRUST Registry is an observational, prospective, long-term, post-market surveillance registry of subjects treated with WallabyPhenox flow modulation devices, stent systems, bifurcation aneurysm implants including their HPC…
- Conditions
- Saccular and Fusiform Aneurysms, Pseudoaneurysm, Vascular Dissection, Perforation
- Trial name
- TRUST (NCT07474935)
- Testing
- Aneurysm Treatment with a Neurovascular Flow Diverter, Dissection Treatment with a Neurovascular Flow Diverter, Perforation Treatment with a Neurovascular Flow Diverter
- Where
- 13 sites in France, Germany and 3 more
- Volunteers
- 5,000 people
- Sponsor
- Phenox GmbH
Intracranial Aneurysm
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
The objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED™ X™ device with the performance of the FRED™ device.
- Trial name
- NCT05409989
- Testing
- FRED™ X™
- Where
- 23 sites in United States
- Volunteers
- 154 people
- Sponsor
- Microvention-Terumo, Inc.
Brain Aneurysm
Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms
This clinical research study is designed to determine safety and effectiveness of the Surpass Flow Diverter (Surpass System), an investigational device developed to treat wide-neck, large or giant intracranial aneurysms.
- Trial name
- SCENT (NCT01716117)
- Testing
- Surpass Flow Diverter
- Where
- 26 sites in United States, Netherlands
- Volunteers
- 213 people
- Sponsor
- Stryker Neurovascular
Intracranial Aneurysms
TransForm™ Occlusion Balloon Catheter Registry
The primary objective of this registry is to collect real world data on the safety and performance of the TransForm™ Occlusion Balloon Catheter when used in current neurointerventional procedures
- Trial name
- NCT01949779
- Testing
- TransForm™ Occlusion Balloon Catheter
- Where
- 7 sites in United States, Spain
- Volunteers
- 81 people
- Sponsor
- Stryker Neurovascular
Brain Aneurysm
Aneurysm Study of Pipeline in an Observational Registry
The primary objective of this study is to further expand the body of clinical knowledge in patients undergoing Pipeline Embolization Device (Pipeline or PED) placement for intracranial aneurysms (IAs or ICAs) according to…
- Trial name
- ASPIRE (NCT01557036)
- Testing
- Pipeline Embolization Device
- Where
- 36 sites in United States, Argentina and 6 more
- Volunteers
- 200 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Brain Aneurysm
CLARYS: CLinical Assessment of WEB® Device in Ruptured aneurYSms
An observational non-randomized, multi-center, prospective assessment of the clinical utility of the WEB Aneurysm Embolization System in subjects with ruptured intracranial aneurysms deemed appropriate for endovascular treatment.
- Trial name
- CLARYS (NCT02687607)
- Testing
- WEB Aneurysm Embolization System
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysm
Endovascular Treatment of Wide Neck Intracranial Aneurysms With the LEO + Stent : The LEO + II Cohort Study
This is a prospective, multicenter, single-arm observational study to evaluate the efficacy and the morbi-mortality of LEO + in patients with wide neck intracranial aneurysms (fusiform, saccular or dissecting), ruptured or not…
- Trial name
- NCT03504436
- Testing
- LEO +
- Volunteers
- 176 people
- Sponsor
- Balt Extrusion
Intracranial Aneurysm
The Artisse™ Intrasaccular Device is Indicated for the Treatment of Wide-neck Bifurcating Intracranial Aneurysms (IAs).
The purpose of this study is to assess the safety and effectiveness of the Artisse™ Intrasaccular Device in the treatment of unruptured and ruptured wide-neck bifurcating intracranial aneurysms.
- Trial name
- ARTISSE (NCT02998229)
- Testing
- Artisse™ Intrasaccular Device
- Where
- 25 sites in United States
- Volunteers
- 300 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Intracranial Arterial Aneurysm
The NUVASCULAR HARBOR Occlusion Device EU Study
The purpose of this study is to evaluate the safety and effectiveness of the HARBOR Occlusion Device for treating brain aneurysms.
- Trial name
- NCT07900464
- Testing
- HARBOR Occlusion Device
- Where
- Bulgaria
- Volunteers
- 30 people
- Sponsor
- Nuvascular Inc
Intracranial Aneurysm
Neuroform Atlas Stent for Intracranial Aneurysm Treatment
The primary objective of this study is to demonstrate effectiveness and safety of the NeuroForm Atlas stent system for use in patients requiring stent assisted intracranial aneurysm treatment.
- Trial name
- ATLAS EU PMCF (NCT02783339)
- Where
- 11 sites in France, Germany and 1 more
- Volunteers
- 105 people
- Sponsor
- Stryker Neurovascular
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.
Aneurysmal Subarachnoid Hemorrhage, Cerebral Vasospasm
Safety Study of Carotid Body Neurostimulation to Treat Cerebral Vasospasm
The purpose of this study is to evaluate the safety and performance of the Delta system in the treatment of cerebral vasospasm post aneurysmal subarachnoid hemorrhage (aSAH) patients.
- Trial name
- NCT02129413
- Testing
- Delta system
- Where
- 7 sites in Czechia, Germany and 1 more
- Volunteers
- 23 people
- Sponsor
- Samson NeuroSciences
Cardiac Rhythm Disorders, Urological Disorders
Product Surveillance Registry
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products.
- Conditions
- Cardiac Rhythm Disorders, Urological Disorders, Neurological Disorders, Cardiovascular Disorders
- Trial name
- PSR (NCT01524276)
- Where
- 402 sites in United States, Argentina and 39 more
- Volunteers
- 100,000 people
- Sponsor
- Medtronic
Intracranial Aneurysms
Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)
The purpose of this study is to evaluate the safety and efficacy of the Low Profile Visualized Intraluminal Support(LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc.
- Trial name
- LVIS (NCT01793792)
- Testing
- LVIS™ and LVIS™ Jr
- Where
- 21 sites in United States
- Volunteers
- 153 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysms, Peripheral Aneurysms
Study of the Penumbra Coil 400 System to Treat Aneurysm
This is a prospective, multi-center study of patients with intracranial or peripheral aneurysms who are treated by the PC 400 System.
- Trial name
- ACE (NCT01465841)
- Testing
- PC 400 coils (Penumbra )
- Where
- 6 sites in United States
- Volunteers
- 517 people
- Sponsor
- Penumbra Inc.
Intracranial Aneurysm
Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment
A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms
- Trial name
- NCT03423290
- Testing
- FRED and FRED Jr
- Where
- 7 sites in United Kingdom
- Volunteers
- 61 people
- Sponsor
- Microvention-Terumo, Inc.
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.