Clinical trials: Wide Neck Aneurysm
Intracranial Aneurysms
Treatment of Intracranial Wide-neck Aneurysms Using Stent-assisted Coil Embolization
This device was designed to assist in the stent-assisted coil embolization of intracranial aneurysms, specifically those that have a wide neck that would not otherwise maintain the coil embolization material within the aneurysm…
- Trial name
- NCT04566263
- Testing
- Neuroform EZ Stent System
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Methodist Health System
Intracranial Aneurysm
Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device
The purpose of this study is to demonstrate effectiveness and safety of the CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System.
- Trial name
- NCT02532517
- Testing
- CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System
- Where
- 11 sites in United States
- Volunteers
- 45 people
- Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
Aneurysm
Enterprise 2 Vascular Reconstruction Device
The primary objective of this study is to collect data regarding the effectiveness of using the Enterprise 2 Reconstruction Device in successfully embolizing intracranial aneurysms with wide neck configuration.
- Trial name
- NCT05254067
- Testing
- Codman Enterprise 2 Vascular Reconstruction Device
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Methodist Health System
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.
Cerebral Aneurysms
Contour Neurovascular System™ ContiNued Access Investigational Device EXempTion (IDE) Trial (NEXT Trial)
The goal of this clinical trial is to collect additional data to demonstrate if the Contour Neurovascular System (CNS) is a safe and effective treatment of wide-necked, saccular, intracranial aneurysms.
- Trial name
- NEXT (NCT06693011)
- Testing
- Contour Neurovascular System Treatment Attempt
- Where
- 9 sites in United States
- Volunteers
- 250 people
- Sponsor
- Cerus Endovascular, Inc.
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.
Wide Neck Bifurcation Intracranial Aneurysms
Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device
A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation.
- Trial name
- WEB PAS (NCT04839705)
- Testing
- WEB
- Where
- 27 sites in United States
- Volunteers
- 195 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysm
pCONus Treatment of Wide Neck Intracranial Aneurysms
To assess safety and efficacy of pCONus for the treatment of wide neck bifurcation aneurysms.
- Trial name
- pToWin (NCT02554708)
- Testing
- implantation of the pCONus Bifurcation Aneurysm Implant
- Where
- 10 sites in Argentina, Austria and 3 more
- Volunteers
- 116 people
- Sponsor
- Phenox GmbH
Aneurysms
The ENTERPRISE Study - Study of the Enterprise Self-Expanding Stent System
To evaluate the safety and feasibility of the Cordis Neurovascular Self-Expanding Stent System to facilitate endovascular coil embolization of wide neck saccular intracranial aneurysms.
- Trial name
- NCT00288405
- Testing
- Cordis Self Expanding Stent
- Where
- Italy
- Volunteers
- 31 people
- Sponsor
- Codman & Shurtleff
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, 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
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
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.
Ruptured Cerebral Aneurysm
A Medical Device to Treat Wide-Neck Brain Aneurysms
The study aims to evaluate the safety and probable benefit of a medical device to treat wide-neck ruptured brain aneurysms.
- Trial name
- TORNADO-US (NCT05550571)
- Testing
- Nautilus Intrasaccular Bridging System
- Where
- 5 sites in United States, Bulgaria
- Volunteers
- 45 people
- Sponsor
- EndoStream Medical
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
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
Unruptured Wide-neck Aneurysms
Citadel Embolization Device Study
The purpose of this study is to gather safety and effectiveness data on Stryker Neurovascular's Next Generation Target Detachable Coil (hereafter referred to as the Citadel Embolization Device), when used with Target Detachable…
- Trial name
- NCT04057352
- Testing
- Citadel Embolization Device
- Where
- 25 sites in United States
- Volunteers
- 150 people
- Sponsor
- Stryker Neurovascular
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
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.
Unruptured Intracranial Aneurysm, Intracranial Bifurcation Aneurysm
Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms
This prospective real-world cohort study aims to compare early postoperative complications between flow diverter treatment and stent-assisted coiling in patients with unruptured wide-neck intracranial bifurcation aneurysms.
- Conditions
- Unruptured Intracranial Aneurysm, Intracranial Bifurcation Aneurysm, Wide-Neck Aneurysm
- Trial name
- FD-SAC BAS (NCT07754188)
- Testing
- Flow Diverter, Stent-Assisted Coiling
- Where
- 3 sites in China
- Volunteers
- 274 people
- Sponsor
- Nanfang Hospital, Southern Medical University