Clinical trials: Brain Aneurysms
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.
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
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
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
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 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.
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
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
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.
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
Success in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS)
The Comaneci Embolization Assist Device is indicated for use in the neurovasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm.
- Trial name
- NCT04518670
- Testing
- Comaneci Embolization Assist Device
- Where
- 8 sites in United States
- Volunteers
- 90 people
- Sponsor
- Rapid Medical
Intracranial Aneurysm
Study to Evaluate Cerebral AneurysmFlow Results in Occlusion
AneurysmFlow R1.0 is an approved (i.e. CE labeled, 510k, Health Canada), software tool intended to provide relevant information on the blood flow in a cerebral aneurysm and its parent artery based on angiography.
- Trial name
- CARO (NCT03663257)
- Testing
- AneurysmFlow
- Where
- 4 sites in United States, Argentina and 1 more
- Volunteers
- 132 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Intracranial Aneurysms
Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device
The purpose of this study is to evaluate the safety and probable benefit of the Low-profile Visualized Intraluminal Support (LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc.
- Trial name
- LVIS (NCT01541254)
- Testing
- Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysms
Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction
This study is designed to evaluate the safety of the PulseRider in patients undergoing treatment for bifurcation basilar or carotid terminus aneurysms.
- Trial name
- ANSWER (NCT02312856)
- Testing
- PulseRider
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Pulsar Vascular
Subarachnoid Hemorrhage
Safety and Pharmacokinetic Evaluation of Nitrite for Prevention of Cerebral Vasospasm
The purpose of the study is to examine the safety of a 14 day infusion of sodium nitrite, and to study the pharmacokinetics of nitrite, during a 14 day infusion in patients with ruptured cerebral aneurysms.
- Trial name
- NCT00873015
- Testing
- Sodium nitrite, Saline
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Hope Pharmaceuticals
Intracranial Aneurysm
Coil Assisted Flow Diversion Safety and Performance Study
Cerus Endovascular is sponsoring a prospective, single arm, multi-center study to document the safety and performance of Neqstent in adjunctive therapy.
- Trial name
- CAFI (NCT04187573)
- Testing
- Neqstent
- Where
- 7 sites in Austria, Canada and 3 more
- Volunteers
- 38 people
- Sponsor
- Cerus Endovascular, Inc.
Intracranial Aneurysm
Neuroform Atlas Stent System Study
The primary objective of this study is to demonstrate effectiveness and safety of the Neuroform Atlas Stent System for use with bare metal embolic coils.
- Trial name
- ATLAS (NCT02340585)
- Testing
- Next Generation Neuroform Stent System
- Where
- 25 sites in United States
- Volunteers
- 298 people
- Sponsor
- Stryker Neurovascular