Clinical trials: Aneurysm, Brain
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
Bioabsorbable/Nufairy Coil Application Trial in China
The scope of this trial is the collection and analysis of effectiveness and safety endpoints, related to the use of the Bioabsorbable/Nufairy Coil Embolization System in the treatment of intracranial aneurysms.
- Trial name
- NuCATCH (NCT06466564)
- Testing
- Nufairy® Coil embolization system for intracranial aneurysm
- Where
- China
- Volunteers
- 258 people
- Sponsor
- MicroPort NeuroTech Co., Ltd.
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
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, 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
Aneurysm Cerebral (Unruptured)
Multimodal Approach Feasability Study for Untreated and Unruptured Intracranial Aneurysms
This feasibility study aims to evaluate the SYLVER system's ability to visualize intracranial aneurysms in accordance with 3D rotational angiography (3DRA) as the reference technique.
- Trial name
- miniCAN (NCT07864389)
- Testing
- 3D CEUS
- Where
- France
- Volunteers
- 15 people
- Sponsor
- Resolve Stroke
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 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 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 Aneurysm
Trenza Embolization Device for Intrasaccular Aneurysm Treatment
The purpose of this Post-Market Clinical Follow-up study is to assess the safety and performance of the Trenza in the treatment of intracranial aneurysms.
- Trial name
- NCT04380350
- Where
- 18 sites in Austria, Finland and 5 more
- Volunteers
- 150 people
- Sponsor
- Stryker Neurovascular
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.
Intracranial Aneurysm
The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System
The objective of the registry is to evaluate the real world safety and performance of the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System (VRD) to facilitate endovascular coil embolization of intracranial…
- Trial name
- SUNRISE (NCT00486226)
- Testing
- Vascular Reconstruction Device
- Where
- Belgium
- Volunteers
- 105 people
- Sponsor
- Codman & Shurtleff
Intracranial Aneurysms
TransForm™ Occlusion Balloon Catheter Registry
The primary objective of this registry is to collect real world data on the safety and performance of the TransForm™ Occlusion Balloon Catheter when used in current neurointerventional procedures
- Trial name
- NCT01949779
- Testing
- TransForm™ Occlusion Balloon Catheter
- Where
- 7 sites in United States, Spain
- Volunteers
- 81 people
- Sponsor
- Stryker Neurovascular
Intracranial Aneurysm
INCA: Intracranial Aneurysm Treatment With NeXsys
Prospective, single center first-in-man study of use of device for intracranial aneurysm occlusion
- Trial name
- INCA (NCT02507531)
- Testing
- NeXsys Embolization System
- Where
- Argentina
- Volunteers
- 3 people
- Sponsor
- Cerus Endovascular, Inc.
Cardiac Diseases, Muscular Weakness
Biomarker for Pompe Disease (BioPompe)
Development of a new MS-based biomarker for the early and sensitive diagnosis of Pompe disease from blood (plasma)
- Conditions
- Cardiac Diseases, Muscular Weakness, Hepato-splenomegaly, Lung Disease
- Trial name
- BioPompe (NCT01457443)
- Where
- 4 sites in Germany, India and 1 more
- Sponsor
- CENTOGENE GmbH Rostock
Aneurysm, Brain
Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities
The objective of this study is to demonstrate the safety and efficacy of the Penumbra SMART COIL® System, including the WAVE™ Extra Soft Coils (WAVE) as a fill and finish coil, in the treatment of intracranial aneurysms.
- Trial name
- SURF (NCT04106583)
- Testing
- WAVE, as part of the SMART COIL System
- Where
- 43 sites in United States, Canada and 4 more
- Volunteers
- 572 people
- Sponsor
- Penumbra Inc.
Intracranial Aneurysm
pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2
To assess safety and efficacy of pCONUS2 for the treatment of wide neck bifurcation aneurysms.
- Trial name
- pToWin2 (NCT03273478)
- Testing
- Endovascular treatment of bifurcation aneurysm with pCONUS2
- Volunteers
- 100 people
- Sponsor
- Phenox 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
Brain Aneurysm
Safety Study of the PulseRider® in Patients Undergoing Treatment for Bifurcation Intracranial Aneurysms
This is a prospective multi-center, single arm, non-randomized study. It is designed to evaluate the safety of the PulseRider® in patients undergoing treatment for bifurcation intracranial aneurysms.
- Trial name
- AWARD (NCT02435823)
- Testing
- PulseRider
- Where
- Austria
- Volunteers
- 35 people
- Sponsor
- Pulsar Vascular
Intracranial Aneurysm
LVIS™ Evo™ and HydroCoil® Embolic System for Intracranial Aneurysm Treatment
This is a prospective multicenter international single-arm observational study to demonstrate that use of stent-assisted coiling with LVIS™ Evo™ and HydroCoil® Embolic System (HES) in intracranial aneurysm treatment is effective…
- Trial name
- SEALANT (NCT04999423)
- Testing
- LVIS EVO and HydroCoil Embolic System
- Where
- 19 sites in Belgium, France and 3 more
- Volunteers
- 206 people
- Sponsor
- Microvention-Terumo, Inc.