Clinical trials: Cranial Aneurysm
Brain Aneurysm
WEB French Observatory of the WEB Aneurysm Embolization System
An observational post-market, open label, multicenter Observatory. The decision to use a WEB device to treat the patients has been made before and independently of the decision to include the patient in the French Observatory.
- Trial name
- NCT01975233
- Testing
- WEB Aneurysm Embolization System
- Where
- 10 sites in France
- Volunteers
- 62 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysms
CARE: A Prospective Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400
The primary objective of this study is to gather data on the radiation exposure in patients treated with the Penumbra Coil 400™ System (PC 400) or conventional coils per their respective indications for use.This is a multicenter…
- Trial name
- CARE (NCT02122133)
- Testing
- PC 400
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- Penumbra Inc.
Intracranial Aneurysm, Aneurysm
Coated Mongolian Aneurysm Treatment Study 2
The purpose of this study is to assess safety and effectiveness of the p64 MW HPC or p48 MW HPC Flow Modulation Device under prasugrel.
- Conditions
- Intracranial Aneurysm, Aneurysm, Vascular Diseases
- Trial name
- COMATS 2 (NCT04305704)
- Where
- Mongolia
- Volunteers
- 90 people
- Sponsor
- Phenox GmbH
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.
Intracranial Aneurysm, Aneurysm
Coated Mongolian Aneurysm Treatment Study 1
The purpose of this study is to assess safety and effectiveness of the p64 MW HPC or p48 MW HPC Flow Modulation Device under Dual Antiplatelet Medication.
- Conditions
- Intracranial Aneurysm, Aneurysm, Vascular Diseases
- Trial name
- COMATS 1 (NCT04305626)
- Testing
- Endovascular treatment of intracranial aneurysms
- Where
- Mongolia
- Volunteers
- 90 people
- Sponsor
- Phenox GmbH
Intracranial Aneurysms
The Reverse Barrel™ VRD Intracranial Aneurysm Trial
The purpose of this clinical investigation is to evaluate the safety and effectiveness of the Barrel™ VRD when used to facilitate endovascular coiling of wide-neck bifurcating or branch intracranial aneurysms with any approved…
- Trial name
- Barrel (NCT02125097)
- Testing
- Barrel™ Vascular Reconstruction Device (VRD)
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
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
Brain Aneurysms
International Retrospective Study of Pipeline Embolization Device
The primary objective of this retrospective study is to determine the incidence of important safety outcomes in patients who have undergone Pipeline Embolization Device placement for intracranial aneurysms (IAs).
- Trial name
- IntrePED (NCT01558102)
- Where
- 17 sites in United States, Argentina and 4 more
- Volunteers
- 793 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Intracranial Aneurysm
Diversion-p64 Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device
The purpose of this study is to assess safety and effectiveness of the p64 Flow Modulation Device.
- Trial name
- NCT02600364
- Where
- 26 sites in Argentina, Belgium and 8 more
- Volunteers
- 450 people
- Sponsor
- Phenox GmbH
Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm, Lesion
Clinical Study of Merlin's DiVeRt - Vascular Reconstruction Device and Delivery System
The objective of the proposed investigation is to assess the safety and effectiveness of the Merlin's DiVeRt system for the treatment of intracranial lesions.
- Trial name
- NCT04589585
- Testing
- DiVeRt
- Where
- Spain
- Volunteers
- 25 people
- Sponsor
- Merlin MD Pte Ltd
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.
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 Aneurysm, Stroke, Ischemic
Neurovascular Product Surveillance Registry
Post market surveillance registry
- Trial name
- INSPIRE (NCT02988128)
- Testing
- Treatment for intracranial aneurysms, Treatment for Acute Ischemic Stroke
- Where
- 99 sites in Argentina, Australia and 22 more
- Volunteers
- 4,000 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Intracranial Aneurysm
Tubridge Flow Diverter Study For Intracranial Aneurysms
The scope of this trial is the collection and analysis of the important safety outcomes in the real world, related to the use of the Tubridge flow diverter in the treatment of intracranial aneurysms.
- Trial name
- TRACE-IA (NCT05646108)
- Testing
- Endovascular treatment
- Where
- China
- Volunteers
- 5,000 people
- Sponsor
- MicroPort NeuroTech Co., Ltd.
Aneurysms
TRUfill®'s Line in Intracranial aNeurysm Embolisation
The objective of this study is to evaluate the long term efficacy and safety of the CODMAN TRUFILL®'s line of coils in the treatment of patients with intracranial ruptured or non-ruptured aneurysms in real-life routine clinical…
- Trial name
- TRULINE (NCT01503775)
- Where
- 7 sites in France
- Volunteers
- 171 people
- Sponsor
- Codman & Shurtleff
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 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 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.
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
Ruptured Aneurysm
European, Multi-center, Exploratory Trial to Assess WEB Versus Other Endovascular Treatment in Ruptured Aneurysms.
Comparison of efficacy and safety between WEB and other endovascular techniques
- Trial name
- WAVE (NCT06511245)
- Testing
- Randomisation
- Where
- France
- Volunteers
- 80 people
- Sponsor
- Microvention-Terumo, Inc.