Clinical trials: Cerebral Aneurysm
Intracranial Aneurysm
Safety and Effectiveness of ENTERPRISE 2 Device in the Endovascular Treatment of Intracranial Aneurysms
The study is designed to evaluate the safety and effectiveness of ENTERPRISE 2 vascular reconstruction device and delivery system (hereinafter referred to as ENTERPRISE 2) to facilitate endovascular coil embolization of…
- Trial name
- EMPOWER (NCT04289480)
- Testing
- ENTERPRISE 2 device
- Where
- 10 sites in China
- Volunteers
- 164 people
- Sponsor
- Medos International SARL
Intracranial Aneurysms
Evaluation of DeltaMaxx® Microcoil System in Intracranial Aneurysms
The primary objective of this registry is to assess the safety and angiographic outcomes of endovascular treatment of intracranial aneurysms using the DeltaMaxx Microcoil System.
- Trial name
- NCT01945827
- Testing
- DeltaMaxx Microcoil System
- Sponsor
- Codman & Shurtleff
Aneurysm, Dissection
PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
The purpose of this registry is to collect safety and performance data on all commercially available Terumo Aortic knitted and woven grafts, and cardiovascular patches in standard clinical practice.
- Conditions
- Aneurysm, Dissection, Aortic Root Aneurysm, Aortic Root Dissection
- Trial name
- PANTHER (NCT04545502)
- Testing
- Gelsoft Plus Vascular Graft, Vascular Bypass Graft, Cardiovascular Patch
- Where
- 30 sites in United States, Belgium and 4 more
- Volunteers
- 2,000 people
- Sponsor
- Vascutek Ltd.
Intracranial Aneurysm
Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment
This is a prospective observational multicenter registry to evaluate safety and efficacy data on Neuroform3TM stenting for treatment with endovascular coiling of wide neck aneurysms on an intent to treat basis.
- Trial name
- SENAT (NCT00928265)
- Testing
- Endovascular treatment of intracranial aneurysm.
- Where
- 12 sites in France
- Volunteers
- 116 people
- Sponsor
- Stryker Neurovascular
Intracranial Aneurysm, Coiling Therapy
Intracranial Aneurysms Treatment With the OPTIMA Coil System
International, non-randomized, European , multicenter, observational study to collect data for the treatment of intracranial aneurysms with OPTIMA coils system to further document its safety and efficacy
- Trial name
- INSTANT (NCT03642821)
- Testing
- intracranial aneurysm coiling
- Where
- 20 sites in Austria, France and 5 more
- Volunteers
- 300 people
- Sponsor
- Balt Extrusion
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.
Aneurysms, Vascular Diseases
Researching AXIUM Coiling Experience and Recanalization (RACER)
The data collected in this study will be used to support International Regulatory submissions. The study objective is to evaluate the continued safety and efficacy of the AXIUM Progressive Coil System.
- Conditions
- Aneurysms, Vascular Diseases, Cerebrovascular Disorders, Intracranial Arterial Diseases
- Trial name
- RACER (NCT00703794)
- Testing
- The AXIUM Progressive Coil System
- Where
- 18 sites in United States
- Volunteers
- 119 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
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
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, 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