Clinical trials: Cranial Aneurysm
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.
Intracranial Aneurysm
FRED Retrospective Study of Intracranial Aneurysms Treatment
To evaluate the long-term safety and efficacy of Flow Re-Direction Endoluminal Device System (FRED) in the treatment of intracranial aneurysms in the post-market environment
- Trial name
- FRED (NCT06982781)
- Testing
- Flow Re-Direction Endoluminal Device System(FRED)
- Volunteers
- 2,000 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysm, Flow Diverter
DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device
To analyse the clinical safety and efficacy of the DERIVO® 2heal® Embolisation Device in the standard clinical routine of flow diversion treatment with respect to the mid- and long-term clinical and angiographic outcomes.
- Trial name
- REheal (NCT05543447)
- Testing
- Flow Diverter Treatment with DERIVO 2 Heal Embolisation Device
- Where
- 17 sites in Germany
- Volunteers
- 158 people
- Sponsor
- Acandis GmbH
Intracranial Aneurysms, Cavernous Carotid Fistula
Neurovascular Embolization Cover for Treatment of Intracranial Aneurysms and Carotid/Vertebrobasilar Fistulae
The purpose of this study is to determine whether the NEC device can effectively occlude the intracranial aneurysm or the carotid/vertebrobasilar fistula and maintain parent vessel patency
- Conditions
- Intracranial Aneurysms, Cavernous Carotid Fistula, Vertebrobasilar Fistula
- Trial name
- NCT01054391
- Testing
- NEC - Neurovascular Embolization Cover
- Where
- 2 sites in Germany
- Volunteers
- 10 people
- Sponsor
- Nfocus Neuromedical
Aneurysm Cerebral
Study to Evaluate the TUBE Device Ability to Treat Unruptured, Wide-neck or Fusiform Aneurysms
To assess the safety and performance of the TUBE device in the endovascular treatment of unruptured, wide-neck or fusiform intracranial aneurysms located on the internal carotid artery (ICA) or its branches
- Trial name
- NV01 (NCT07079956)
- Testing
- TUBE Flow Diverter
- Where
- 3 sites in Brazil
- Volunteers
- 20 people
- Sponsor
- NVMedTech
Aneurysm, Intracranial
An EFS Assessing the Electrolytic eCLIPs System for Treatment of Intracranial Aneurysms
The purpose of this study is to investigate the feasibility and initial clinical safety of eCLIPs device use for the treatment of wide-necked bifurcation aneurysms.
- Trial name
- NCT04886505
- Testing
- Electrolytic eCLIPs Bifurcation System
- Sponsor
- Evasc Medical Systems Corp.
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, Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion
Microvention AnEurysm & STroke Real-life Data cOllection
The MAESTRO registry is a post-market, single-arm, non-interventional, multicenter registry
- Conditions
- Intracranial Aneurysm, Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion, Aneurysmal Subarachnoid Hemorrhage, Ischemic Stroke
- Trial name
- MAESTRO (NCT06494436)
- Testing
- All Microvention Class III implantable device CE marked, All Microvention Mechanical Thrombectomy Class III device CE marked
- Where
- Spain
- Volunteers
- 1,000 people
- Sponsor
- Microvention-Terumo, Inc.
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
Intracranial Aneurysms
Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment
A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms.
- Trial name
- SAFE (NCT02921698)
- Testing
- FRED®
- Volunteers
- 100 people
- Sponsor
- Microvention-Terumo, Inc.
Unruptured Intracranial Aneurysm
Assessment of the Clinical and Economic Impact of Sim&Size, a Simulation Software for Implantable Devices Used in the Treatment of Intracranial Aneurysms: A Prospective Multicenter Study.
In recent years, endovascular treatment of intracranial aneurysms has seen remarkable growth, now surpassing traditional surgical approaches in terms of frequency of use.
- Trial name
- ESSNAI (NCT07433075)
- Testing
- 3D simulation of placement of neurovascular implantable medical device, Manual planning of endovascular procedure
- Where
- 6 sites in France
- Volunteers
- 576 people
- Sponsor
- Sim&Cure
Intracranial Aneurysm
PARAT PLUS (The Tubridge Plus For The Treatment Of Wide-Necked Intracranial Aneurysms)
A trial to evaluate the safety and efficacy of the Tubridge Plus flow-diverter stent for the treatment of intracranial wide-necked aneurysms.
- Trial name
- NCT05898893
- Testing
- Microport NeuroTech Tubridge Plus flow-diverter Stent
- Where
- 8 sites in China
- Volunteers
- 99 people
- Sponsor
- MicroPort NeuroTech Co., Ltd.
Subarachnoid Hemorrhage, Ruptured Intracranial Aneurysm
Safety and Efficacy Study of a Single Dose of NA-1 in Patients Undergoing Endovascular Repair of Ruptured Aneurysms
This is a randomized, double-blind, placebo-controlled, single-dose study investigating the safety and efficacy of NA-1 in patients with subarachnoid hemorrhage (SAH) undergoing endovascular repair of ruptured intracranial…
- Trial name
- ENACT-2 (NCT02056574)
- Testing
- NA-1
- Where
- 12 sites in United States, Canada
- Sponsor
- NoNO Inc.
Aneurysms
A Study to Look at Performance of MICRUSFRAME and GALAXY Coils for the Treatment of Intracranial Aneurysms
A post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils
- Trial name
- STERLING (NCT03642639)
- Testing
- MICRUSFRAME and GALAXY coils
- Where
- 51 sites in United States, Belgium and 8 more
- Volunteers
- 723 people
- Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
Intracranial Aneurysm
Safety and Performance of the Neuroform Atlas™ Stent System
The objective of this retrospective study is to describe in real-life settings the clinical practice, utilization and the treated population outcomes at 1-year (12-16 months) follow-up at selected, representative centers in…
- Trial name
- ATLAS-FR (NCT04162483)
- Testing
- Neuroform Atlas Stent System
- Where
- France
- Volunteers
- 310 people
- Sponsor
- Stryker Neurovascular
Aneurysm Cerebral, Bifurcation
LUMENS-1 Canada Early Feasibility Study Clinical Investigation Plan
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
- NCT07259018
- Testing
- LuSeed Aneurysm Embolization System
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- LuSeed Vascular LTD.
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
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