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
Intracranial Aneurysm
Flow Diverter Stent for Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms
Unruptured saccular intracranial aneurysms larger than 7 mm can be treated with endovascular occlusion using detachable coils, with or without expendable stent assistance.
- Trial name
- EVIDENCE (NCT01811134)
- Testing
- PIPELINE flow diverter stent, Coils, with or without expendable stent
- Where
- France
- Volunteers
- 91 people
- Sponsor
- Hospices Civils de Lyon
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
Prospective Packing Density With Target Coils I
This is a prospective single center trial investigating the effects of prospectively measuring packing density prior to choosing Target Coils for the treatment of intracranial saccular aneurysms.
- Trial name
- PropackI (NCT02292017)
- Testing
- Embolization of intracranial aneurysm
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Tennessee Neurovascular Institute, LLC
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.
Wide Neck Saccular Cerebral Aneurysms
Endovascular Treatment of Wide Neck Saccular Cerebral Aneurysms
Intracranial aneurysm (IA) is a cerebrovascular disorder in which the weakness of a cerebral artery wall causes a localized dilation of the blood vessel.
- Trial name
- NCT05796986
- Testing
- Endovascular procedure of treatment of wide neck saccular cerebral aneurysm
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Sohag University
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, Brain Aneurysm
The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices
Intracranial bifurcation aneurysms are commonly repaired with surgical and with endovascular techniques. Wide-necked bifurcation aneurysms (WNBA) are a difficult subset of aneurysms to successfully repair endovascularly, and a…
- Conditions
- Intracranial Aneurysm, Brain Aneurysm, Unruptured Cerebral Aneurysm, Ruptured Cerebral Aneurysm
- Trial name
- RISE (NCT03936647)
- Testing
- surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling, WEB embolization device
- Where
- 4 sites in Canada
- Volunteers
- 250 people
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
Intracranial Aneurysm
Clinical Performance Evaluation of RDX-Aneurysm for Detecting Intracranial Aneurysms on TOF-MRA
This retrospective, multi-center, observational case-control study evaluates the standalone performance of RDX-Aneurysm, a computer-assisted detection software, for detecting and marking suspected saccular intracranial aneurysm…
- Trial name
- RDX-Aneurysm (NCT07655635)
- Where
- 3 sites in Taiwan
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- Taipei Medical University Shuang Ho Hospital
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.