Clinical trials: Aneurysm, Brain
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
Intracranial Aneurysm
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
The objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED™ X™ device with the performance of the FRED™ device.
- Trial name
- NCT05409989
- Testing
- FRED™ X™
- Where
- 23 sites in United States
- Volunteers
- 154 people
- Sponsor
- Microvention-Terumo, Inc.
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.
Brain Diseases, Aneurysm
PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SINGLE-ARM REGISTRATION TRIAL OF THE TUBRIDGE FOR THE TREATMENT OF WIDE-NECKED SMALL AND MEDIUM-SIZED INTRACRANIAL ANEURYSMS
A trial to evaluate the safety and efficacy of the Tubridge flow-diverter stent for the treatment of intracranial wide-necked, small to medium-sized aneurysms.
- Conditions
- Brain Diseases, Aneurysm, Intracranial Aneurysm, Cardiovascular Diseases
- Trial name
- NCT05829746
- Testing
- Tubridge
- Where
- China
- Volunteers
- 65 people
- Sponsor
- MicroPort NeuroTech Co., Ltd.
Unruptured Intracranial Aneurysm, Arteriovenous Cerebral Malformations
ACtive Catheterization for EndovaScular TreatmentS
The objective of this clinical investigation is to evaluate the safety and technical success of the Basecamp Vascular controllable directional GECKO guidewire when used to facilitate endovascular access to the targeted vessel in…
- Conditions
- Unruptured Intracranial Aneurysm, Arteriovenous Cerebral Malformations, Carotid Stenosis
- Trial name
- ACCESS (NCT05355259)
- Testing
- GECKO Active Guidewire
- Where
- France
- Volunteers
- 10 people
- Sponsor
- Basecamp Vascular
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.
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
Enterprise Stent Aneurysm Treatment (ESAT) Study - France
The purpose of this study is to evaluate the morbidity, mortality, and efficacy of use of the Enterprise(TM) stent for the treatment of (ruptured or non-ruptured) intracranial aneurysms.
- Trial name
- ESAT (NCT00879580)
- Where
- 14 sites in France
- Volunteers
- 133 people
- Sponsor
- Codman & Shurtleff
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
French eCLIPs™ Efficacy and Safety Investigation
The objective of this study is to demonstrate the safety and efficacy of the eCLIPs™ products for the treatment of bifurcation aneurysms.
- Trial name
- EESIS-Fr (NCT05330897)
- Testing
- Implantation of an eCLIPs™ device, eCLIPs™ Electrolytic Bifurcation Systems
- Where
- 28 sites in France
- Volunteers
- 119 people
- Sponsor
- Evasc Medical Systems Corp.
Intracranial Aneurysm
Safety and Efficacy Analysis of FRED™/FRED™Jr 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
- NCT03423290
- Testing
- FRED and FRED Jr
- Where
- 7 sites in United Kingdom
- Volunteers
- 61 people
- Sponsor
- Microvention-Terumo, Inc.
Tumor, Cerebral Ventricle, Tumor, Cerebellar
Post Market Clinical Follow-Up Study on the Performance and Safety of Lyoplant®
Retrospective, single center, single arm PMCF study on the performance and safety of Lyoplant® used for the replacement and extension of connective tissue structures in neurosurgery.
- Conditions
- Tumor, Cerebral Ventricle, Tumor, Cerebellar, Aneurysm Cerebral, Trauma, Brain
- Trial name
- LYOPLACE (NCT05441618)
- Testing
- Lyoplant®
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Aesculap AG
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
Intracranial Aneurysm
Evaluation of Safety and Efficacy of the Accero® (Heal) Stent for Intracranial Aneurysm Treatment
This study is intended to show that the application of the Accero® (heal) stent is safe within the given indication.
- Trial name
- NCT03957382
- Testing
- Accero® (heal) Stent
- Where
- 4 sites in Germany
- Volunteers
- 130 people
- Sponsor
- Acandis GmbH
Intracranial Aneurysm, Flow Diverter
Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment
The FIRST study is an observational, prospective, multi-center, international, single-arm, study. The aim of the study is to collect safety and efficacy information on the use of the silk vista and silk vista baby flow diverter…
- Trial name
- FIRST (NCT04034810)
- Testing
- Intracranial aneurysm treated with Silk vista and silk vista baby
- Where
- 29 sites in Austria, Belgium and 7 more
- Volunteers
- 234 people
- Sponsor
- Balt Extrusion
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.
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 Aneurysms
A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System
This study is a prospective, multi-center registry of patients with intracranial aneurysms who are treated by the PC 400 System. Data for each patient are collected up to 12 ± 3 months post-procedure for the study.
- Trial name
- VOLCAN (NCT01754051)
- Testing
- PC 400 coils
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Penumbra Inc.
Intracranial Aneurysms
Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device
The purpose of this study is to evaluate the safety and probable benefit of the Low-profile Visualized Intraluminal Support (LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc.
- Trial name
- LVIS (NCT01541254)
- Testing
- Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysm
WEB Clinical Assessment of IntraSaccular Aneurysm Therapy
The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm Embolization System used to embolize intracranial aneurysms
- Trial name
- WEBCAST (NCT01778322)
- Testing
- Intracranial aneurysm embolization
- Where
- 12 sites in Denmark, France and 2 more
- Volunteers
- 51 people
- Sponsor
- Microvention-Terumo, Inc.