Clinical trials: Cranial Aneurysm
Wide Neck Bifurcation Intracranial Aneurysms, Intracranial Aneurysms
The WEB-IT Clinical Study
The study is a prospective, multicenter single-arm cohort. Patients with wide neck bifurcation aneurysms (WNBAs) have few choices for safe and effective endovascular treatment.
- Trial name
- WEB-IT (NCT02191618)
- Testing
- WEB
- Where
- 32 sites in United States, Canada and 4 more
- Volunteers
- 150 people
- Sponsor
- Microvention-Terumo, Inc.
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.
Aneurysm, Intracranial Aneurysm
Appraising the Embolization of Aneurysms Using Balt Optima™ Coil System (APPLY Study)
In recent years, many developments have been made to the tools and techniques used to treat IAs via endovascular intervention. Specifically, to the detachable coils themselves.
- Conditions
- Aneurysm, Intracranial Aneurysm, Ruptured Aneurysm, Subarachnoid Hemorrhage, Aneurysmal
- Trial name
- APPLY (NCT04499508)
- Testing
- Optima Coil System
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Vascular Neurology of Southern California Inc.
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, Peripheral Aneurysms
Study of the Penumbra Coil 400 System to Treat Aneurysm
This is a prospective, multi-center study of patients with intracranial or peripheral aneurysms who are treated by the PC 400 System.
- Trial name
- ACE (NCT01465841)
- Testing
- PC 400 coils (Penumbra )
- Where
- 6 sites in United States
- Volunteers
- 517 people
- Sponsor
- Penumbra Inc.
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.
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, AVM - Cerebral Arteriovenous Malformation
Postmarket Study of Tarvos Microguidewire in Neurovascular Interventional Surgery
This investigation is to evaluate the clinical effectiveness and safety of the Tarvos Microguidewire in the neurovascular interventional surgery.
- Conditions
- Intracranial Aneurysm, AVM - Cerebral Arteriovenous Malformation, AV Fistula, Acute Ischemic Stroke
- Trial name
- NCT07500155
- Testing
- Tarvos Microguidewire
- Where
- China
- Volunteers
- 121 people
- Sponsor
- Keuro MedTech
Cerebral Aneurysm
A Medical Device to Treat Brain Aneurysms
An aneurysm is a bulge in a blood vessel caused by a weakness in the blood vessel wall, usually where it branches. As blood passes through the weakened blood vessel, the blood pressure causes a small area to bulge outwards like a…
- Trial name
- NCT04963933
- Testing
- Nautilus endovascular device
- Where
- 2 sites in Bulgaria, Latvia
- Volunteers
- 30 people
- Sponsor
- EndoStream Medical
Intracranial Aneurysm
FRED and FRED JR Devices for Intracranial Aneurysm Treatment
A French, multicenter, prospective, observational, "real-world" assessment of the safety and efficacy of FRED and FRED Jr devices in the treatment of intracranial aneurysms
- Trial name
- NCT04315168
- Testing
- FRED and FRED JR
- Where
- France
- Volunteers
- 135 people
- Sponsor
- Microvention-Terumo, Inc.
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
Cardiac Rhythm Disorders, Urological Disorders
Product Surveillance Registry
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products.
- Conditions
- Cardiac Rhythm Disorders, Urological Disorders, Neurological Disorders, Cardiovascular Disorders
- Trial name
- PSR (NCT01524276)
- Where
- 402 sites in United States, Argentina and 39 more
- Volunteers
- 100,000 people
- Sponsor
- Medtronic
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
Intracranial Aneurysms
PMCF Registry to Describe the Safety and Performance of p64, p48 MW and p64 MW in France
To evaluate safety and performance of the phenox GmbH Flow Diverter p64, p64 MW, and p48MW in France, this registry will include subjects with intracranial aneurysms (anterior and posterior) who are treated with a phenox GmbH…
- Trial name
- CEFloW (NCT07748572)
- Testing
- Aneurysm treatment with a Flow Modulation Device
- Where
- 11 sites in France
- Volunteers
- 200 people
- Sponsor
- Phenox GmbH
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
Coil Assisted Flow Diversion Safety and Performance Study
Cerus Endovascular is sponsoring a prospective, single arm, multi-center study to document the safety and performance of Neqstent in adjunctive therapy.
- Trial name
- CAFI (NCT04187573)
- Testing
- Neqstent
- Where
- 7 sites in Austria, Canada and 3 more
- Volunteers
- 38 people
- Sponsor
- Cerus Endovascular, Inc.
Intracranial Aneurysm
INSPIRE Pipeline™ Shield Post Approval Study
The purpose of the Pipeline™ Flex Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Shield PAS") is to collect on-label use data in patients undergoing treatment for intracranial aneurysms (IA)…
- Trial name
- NCT05071963
- Testing
- Treatment of Intracranial Aneurysms
- Where
- 16 sites in United States
- Volunteers
- 246 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
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
Subarachnoid Hemorrhage
Safety and Pharmacokinetic Evaluation of Nitrite for Prevention of Cerebral Vasospasm
The purpose of the study is to examine the safety of a 14 day infusion of sodium nitrite, and to study the pharmacokinetics of nitrite, during a 14 day infusion in patients with ruptured cerebral aneurysms.
- Trial name
- NCT00873015
- Testing
- Sodium nitrite, Saline
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Hope Pharmaceuticals