Clinical trials: Cranial Aneurysm
Intracranial Aneurysm
Endovascular Treatment of Wide Neck Intracranial Aneurysms With the LEO + Stent : The LEO + II Cohort Study
This is a prospective, multicenter, single-arm observational study to evaluate the efficacy and the morbi-mortality of LEO + in patients with wide neck intracranial aneurysms (fusiform, saccular or dissecting), ruptured or not…
- Trial name
- NCT03504436
- Testing
- LEO +
- Volunteers
- 176 people
- Sponsor
- Balt Extrusion
Intracranial Aneurysm
The Flow Diverter for Treating Patients With Intracranial Aneurysms
To evaluate the efficacy and safety of the blood flow guide device manufactured by Jiangsu Changyida Medical Technology Co., Ltd. for endovascular embolization of intracranial aneurysms
- Trial name
- NCT05060185
- Testing
- the Flow Diverter
- Volunteers
- 166 people
- Sponsor
- Jiangsu CED Medtech Co., Ltd
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.
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.
Ruptured and Unruptured Intracranial Aneurysms
Mid-term Data Collection of the Treatment of Intracranial Aneurysms With the WEB™ Aneurysm Embolization System
Flow disruption is a new endovascular approach for treatment of both ruptured and unruptured intracranial aneurysms, which involves placement of an endosaccular device (WEB) which modifies the blood flow at the level of the neck…
- Trial name
- NCT03312725
- Testing
- WEB aneurysm embolization system
- Where
- Belgium
- Volunteers
- 1 people
- Sponsor
- Medical Therapy Solutions
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
Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil
The primary objective of this study is to gather post market data on the Penumbra SMART COIL® System (Smart System) in the treatment of intracranial aneurysms and other malformations.
- Trial name
- SMART (NCT02729740)
- Testing
- Penumbra Smart Coil, Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)
- Where
- 72 sites in United States, Canada
- Volunteers
- 995 people
- Sponsor
- Penumbra Inc.
Intracranial Aneurysm
Pivotal Study of the Silk Vista Baby Flow Diverters in the Treatment of Unruptured Intracranial Aneurysms (PIONEER)
The PIONEER Study is a pivotal, multi-center, prospective, single-arm study designed to evaluate the safety and efficacy of the Silk Vista Baby (SVB) Flow Diverter for the treatment of unruptured aneurysms.
- Trial name
- PIONEER (NCT07225075)
- Testing
- Silk Vista Baby (SVB) Flow Diverter
- Where
- 6 sites in United States, Canada
- Volunteers
- 250 people
- Sponsor
- Balt USA
Heart Failure, Cardiomyopathies
Multimodal Physiologic State Intelligence Study
The OMNIPHYS study will investigate whether multimodal ultrasound and other routinely collected clinical and physiologic data can be combined with artificial intelligence to characterize changes in a person's physiologic state…
- Conditions
- Heart Failure, Cardiomyopathies, Pulmonary Hypertension, Myocarditis; Acute or Subacute
- Trial name
- OMNIPHYS (NCT07814118)
- Testing
- OMNIPHYS Multimodal Ultrasound Imaging System
- Where
- United States
- Volunteers
- 25,000 people, healthy volunteers welcome
- Sponsor
- Truway Health, 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
Cerebral Aneurysm
Surpass Flow Diverter for Intracranial Aneurysms: SURMOUNT Registry Data Collection
The purpose of this observational post-marketing registry will be to collect and analyze safety, effectiveness, and quality of life outcomes, during and after treatment with the Surpass Flow Diverter.
- Trial name
- NCT02281721
- Testing
- Surpass Flow Diverter(s)
- Where
- 19 sites in Belgium, Finland and 7 more
- Volunteers
- 150 people
- Sponsor
- Stryker Neurovascular
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
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.
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
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, Ruptured Aneurysm
EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization Device With Shield TEchnology™ (ELEVATE)
The purpose of the study is to assess the safety and effectiveness of the Pipeline™ Flex Embolization Device with Shield Technology™ in the treatment with acutely ruptured intracranial aneurysms.
- Trial name
- ELEVATE (NCT04391803)
- Testing
- Pipeline™ Flex Embolization Device with Shield Technology™
- Where
- 7 sites in United States
- Volunteers
- 25 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Unruptured Wide-neck Intracranial Aneurysms
A Study Evaluating the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm
This is a prospective, multi-center, non-randomized clinical evaluation utilizing the PulseRider® Aneurysm Neck Reconstruction Device.
- Trial name
- NAPA (NCT03383666)
- Testing
- PulseRider® Aneurysm Neck Reconstruction Device
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Pulsar Vascular
Intracranial Aneurysm
Post-Market Clinical Follow-Up Study to Confirm Clinical Performance and Safety of the Codman Enterprise® 2 Vascular Reconstruction Device in the Endovascular Treatment of Intracranial Aneurysms
The objective of this Post-Market Clinical Follow-up (PMCF) is to confirm the performance and safety of the Codman Enterprise® 2 when used in conjunction with endovascular coil embolization of ruptured or non-ruptured…
- Trial name
- SUNRISE-2 (NCT02415010)
- Testing
- Enterprise 2 Vascular Reconstruction Device
- Where
- 10 sites in Germany, Spain and 2 more
- Volunteers
- 26 people
- Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
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.
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