Clinical trials: Saccular Aneurysm
Intracranial Aneurysm
SEAL™IT: Saccular Endovascular Aneurysm Lattice System Interventional Pivotal Trial
To establish the safety and effectiveness of the SEAL™ Saccular Endovascular Aneurysm Lattice system for the treatment of saccular intracranial aneurysms.
- Trial name
- SEAL™IT (NCT05831202)
- Testing
- The SEAL™ Saccular Endovascular Aneurysm Lattice System
- Where
- 6 sites in United States
- Volunteers
- 279 people
- Sponsor
- Galaxy Therapeutics INC
Aneurysm, Aneurysm, Ruptured
SEAL™ME: Saccular Endovascular Aneurysm Lattice System Multicenter Enrollment Global Registry
Prospective, international, single-arm, multicenter, registry study. Patients presenting with evidence of Wide Neck unruptured or ruptured intracranial aneurysm (≤ 20 mm in widest diameter) requiring treatment will be enrolled…
- Trial name
- SEAL™ME (NCT05880680)
- Testing
- SEAL Device
- Where
- 4 sites in Colombia, New Zealand and 2 more
- Volunteers
- 200 people
- Sponsor
- Galaxy Therapeutics INC
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
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
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, 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
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
Intracranial, Wide-Neck, Saccular Aneurysms
Study of the Enterprise Self-Expanding Stent System With Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms
Cordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel
- Trial name
- NCT00233753
- Testing
- Cordis Neurovascular Self-Expanding Stent
- Volunteers
- 30 people
- Sponsor
- Codman & Shurtleff
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.
Intracranial Aneurysms
Canadian eCLIPs™ Safety and Feasibility Study Protocol
The purpose of this study is to evaluate the safety and feasibility of the eCLIPs™ Family of Products for the treatment of unruptured intracranial bifurcation aneurysms in conjunction with embolization coils.
- Trial name
- CESIS (NCT01957683)
- Testing
- eCLIPs™ Family of Products
- Where
- 5 sites in Canada
- Sponsor
- Evasc Medical Systems Corp.
Ruptured Cerebral Aneurysm, Ruptured Berry Aneurysm
Safety and Tolerability Study of EG-1962 in Aneurysmal Subarachnoid Hemorrhage
Phase 1/2a Multicenter, Controlled, Randomized, Open Label, Dose Escalation, Safety, Tolerability, and Pharmacokinetic Study Comparing EG-1962 and Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage
- Trial name
- NEWTON (NCT01893190)
- Testing
- Nimodipine, Nimodipine Microparticles
- Where
- 23 sites in United States, Canada and 2 more
- Volunteers
- 73 people
- Sponsor
- Edge Therapeutics Inc
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.
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.
Aneurysms Saccular, Aneurysm, Ruptured
Pre-SEAL™IT: Saccular Endovascular Aneurysm Lattice System First In Human Interventional Trial
To establish the preliminary safety and effectiveness of the SEAL™ Endovascular Aneurysm Lattice System for the treatment of saccular intracranial aneurysms. The data from this study will be used to support: 1.
- Conditions
- Aneurysms Saccular, Aneurysm, Ruptured, Aneurysm
- Trial name
- Pre-SEAL™IT (NCT05686733)
- Testing
- SEAL Device
- Where
- Colombia
- Volunteers
- 26 people
- Sponsor
- Galaxy Therapeutics 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.
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.
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.
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.