Clinical trials: Intracranial Arterial Aneurysm
Intracranial Aneurysms
Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE
The aims of this clinical data collection are to investigate mortality, morbidity and neurological outcome 12 months after treatment of subject's intracranial aneurysm(s) and additionally to evaluate potential residual risks…
- Trial name
- ANCRAGE PMS (NCT06940934)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Acandis 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.
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
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 Cerebral
Kaneka Endovascular Embolization and Protection
Prospective, multi-center, non-randomized registry / study, up to 164 patients enrolled and followed at 180 days +/- 45 days and again at 365 days +/- 90 days post procedure
- Trial name
- KEEP (NCT05563051)
- Testing
- i-ED COIL
- Where
- 4 sites in United States
- Volunteers
- 164 people
- Sponsor
- Kaneka Medical America LLC
Intracranial Aneurysm
Efficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms
The purpose of this study is to assess the efficacy and safety of the Flow Diverter (Tonbridge) for endovascular treatment of intracranial aneurysms.
- Trial name
- NCT04799964
- Testing
- Flow Diverter (Tonbridge), Tubridge (MicroPort)
- Where
- 13 sites in China
- Volunteers
- 187 people
- Sponsor
- Ton-Bridge Medical Tech. Co., Ltd
Intracranial Aneurysm, Brain Arterial Disease
Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform
BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices.
- Conditions
- Intracranial Aneurysm, Brain Arterial Disease, Acute Ischemic Stroke, Peripheral Vascular Diseases
- Trial name
- EVIDENCE (NCT04927156)
- Testing
- BALT medical devices
- Where
- 12 sites in France, Germany and 1 more
- Volunteers
- 10,000 people
- Sponsor
- Balt Extrusion
Intracranial Aneurysm
The Artisse™ Intrasaccular Device is Indicated for the Treatment of Wide-neck Bifurcating Intracranial Aneurysms (IAs).
The purpose of this study is to assess the safety and effectiveness of the Artisse™ Intrasaccular Device in the treatment of unruptured and ruptured wide-neck bifurcating intracranial aneurysms.
- Trial name
- ARTISSE (NCT02998229)
- Testing
- Artisse™ Intrasaccular Device
- Where
- 25 sites in United States
- Volunteers
- 300 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Cerebral Aneurysm, Cerebral Aneurysm Unruptured
Parent Artery Reconstruction for Cerebral Aneurysms Using a Novel Flow Diverter With Surface Modification
The primary objective of this trial is to evaluate the safety and efficacy of the cerebral flow diverter in the endovascular treatment of wide-necked cerebral aneurysms
- Trial name
- NCT05774782
- Testing
- Cerebral flow diverter
- Where
- China
- Volunteers
- 143 people
- Sponsor
- Sinomed Neurovita Technology Inc.
Intracranial Aneurysm
Safety & Performance of the World Medica World Diverter Embolization Device
The objective of this study is to investgiate the safety and clinical performance of the World Diverter Emoblization Device for the endovascular treatment of wide-neck (neck width ≥ 4 mm or dome-to-neck ratio <2) or fusiform…
- Trial name
- NCT07339358
- Testing
- Flow diverter implantation
- Where
- Spain
- Volunteers
- 72 people
- Sponsor
- World Medica USA, LLC
Intracranial Aneurysms
Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS Device
The proposed study is a multi-center single arm retrospective and prospective data collection, of patients treated with the LVIS device of specific sizes of 3.5mm, 4.0mm, 4.5mm, 5.5mm with up to 5 years follow-up.
- Trial name
- LVIS PAS (NCT05453240)
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysm
FRED/ FRED Jr/ FRED X Intracranial Aneurysm Treatment Study
A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms
- Trial name
- FRITS (NCT03920358)
- Testing
- FRED, FRED Jr and FRED X
- Where
- Germany
- Volunteers
- 156 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysm
A Single-arm Trial of the Flow Diverter (Tonbridge) For Endovascular Treatment of Intracranial Aneurysms
The purpose of this study is to assess the effectiveness and safety of the Flow Diverter (Tonbridge) by collecting data from subjects who receive endovascular treatment of intracranial aneurysms.
- Trial name
- NCT04918420
- Testing
- Flow Diverter (Tonbridge)
- Where
- 7 sites in China
- Volunteers
- 142 people
- Sponsor
- Ton-Bridge Medical Tech. Co., Ltd
Intracranial Aneurysm
To Evaluate the Safety and Effectiveness of Flow Modulation Device for Intracranial Aneurysms
The purpose of this study is to assess safety and effectiveness of the p64/p48 MW HPC Flow Modulation Device.
- Trial name
- NCT06158750
- Testing
- p64/p48 MW HPC Flow Modulation Device
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shanghai Wallaby Medical Technologies Co.,Inc.
Intracranial Aneurysm
Axium Coil in Completing Endovascular Aneurysm Surgery Study
The current observational evaluation is designed to evaluate the performance of the Axium™ MicroFx™ Detachable Coil System for the treatment of intracranial aneurysms in the real life practice.
- Trial name
- ACCESS (NCT01194388)
- Testing
- MicroFx™ PGLA COILS
- Where
- United States
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Aneurysm, Intracranial
US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair
The purpose of this trial is to gather data on the safety and effectiveness of the Contour /Contour 021 System in the treatment of wide-necked bifurcated saccular, intracranial aneurysms for submission to FDA in support of a…
- Trial name
- NECC (NCT04852783)
- Testing
- Contour Neurovascular System
- Where
- 20 sites in United States
- Volunteers
- 250 people
- Sponsor
- Cerus Endovascular, Inc.
Intracranial Bifurcating Aneurysms
Reverse Medical Barrel™ Device for Adjunctive Treatment for Wide-Neck, Intracranial, Bifurcating/Branching Aneurysms
Single arm study to evaluate the outcomes of treatment with the Barrel VRD device as an adjunctive treatment to coiling for wide neck, intracranial, bifurcating/branching aneurysms in the middle cerebral and basilar arteries.
- Trial name
- NCT02179190
- Testing
- BARREL VRD
- Where
- 3 sites in United States
- Volunteers
- 138 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
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
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
Pilot Study of the Contour Neurovascular SystemTM
Prospective, single arm, multi centre study to evaluate the safety and performance of the Contour Neurovascular SystemTM in the treatment of intracranial aneurysm (IA)
- Trial name
- NCT02784431
- Testing
- Contour Neurovascular System placement
- Volunteers
- 20 people
- Sponsor
- Cerus Endovascular, Inc.