Clinical trials: Intracranial Aneurysms
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 Aneurysms
MAPS Trial: Matrix And Platinum Science
Primary Objectives: To establish Target Aneurysm Recurrence (TAR) rates for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular aneurysms.
- Trial name
- MAPS (NCT00396981)
- Testing
- Matrix 2® coils for endovascular aneurysm occlusion, GDC® coils for endovascular aneurysm occlusion
- Where
- 43 sites in United States, Australia and 9 more
- Volunteers
- 626 people
- Sponsor
- Stryker Neurovascular
Intracranial Aneurysm, Subarachnoid Hemorrhage
PRET: Patients Prone to Recurrence After Endovascular Treatment
The PRET study aims at comparing two types of coils used in the endovascular treatment of intracranial aneurysms. The first type made of platinum has been used for more than 15 years.
- Trial name
- PRET (NCT00626912)
- Testing
- endovascular coil embolization
- Where
- 32 sites in United States, Canada and 4 more
- Volunteers
- 447 people
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
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
Subarachnoid Hemorrhage
Treatment of Subarachnoid Hemorrhage With Human Albumin
The purpose of this study is to evaluate the tolerability and safety of 25 percent human albumin therapy in patients with subarachnoid hemorrhage.
- Trial name
- NCT00283400
- Testing
- 25% human albumin
- Where
- 6 sites in United States, Canada
- Volunteers
- 47 people
- Sponsor
- Baylor College of Medicine
Brain Aneurysm
Trial on Endovascular Aneurysm Management
The management of patients with unruptured aneurysms is controversial. Patients with unruptured aneurysms may suffer intracranial hemorrhage, but the incidence of this event is still debated.
- Trial name
- TEAM (NCT00537134)
- Testing
- Embolization, coiling
- Where
- 9 sites in United States, Canada and 2 more
- Volunteers
- 80 people
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
Subarachnoid Hemorrhage, Hypertension
Safety and Efficacy Study of Clevidipine to Control Hypertension in Patients Admitted With Aneurysmal Subarachnoid Hemorrhage
This study is designed to assess how rapidly and how safely Clevidipine can be used to control high Blood Pressure in patients with subarachnoid hemorrhage which is a type of brain bleed that happens because of a weak balloon…
- Trial name
- CLASH (NCT00978822)
- Testing
- Clevidipine butyrate injectable emulsion
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Henry Ford Health System
Intracranial Aneurysms, Seizure
Seizure Prophylaxis in Aneurysm Repair
After a thorough review of the existing literature as well as a review of our own practice, the investigators have concluded that the decision to treat patients undergoing aneurysm repair with levetiracetam has reached true…
- Trial name
- SPAR (NCT01801072)
- Testing
- Levetiracetam
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- University of Michigan
Intracranial Aneurysm
Pipeline™ Vantage Embolization Device With Shield Technology™ for Wide-Necked Intracranial Aneurysms (ADVANCE)
The purpose of this study is to assess the safety and effectiveness of the Pipeline™ Vantage Embolization Device with Shield Technology™ in the treatment of intracranial aneurysms within the intended indication for use.
- Trial name
- ADVANCE (NCT03873714)
- Testing
- Pipeline™ Vantage Embolization Device with Shield Technology™
- Where
- 3 sites in United States
- Volunteers
- 14 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Intracranial Aneurysms
Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms
The purpose of this study is to evaluate the safety and effectiveness of the MicroVention Flow Redirection Intraluminal Device (FRED) system when used in the treatment of wide-necked intracranial aneurysms.
- Trial name
- FRED (NCT01801007)
- Testing
- Flow Re-Direction Endoluminal Device (FRED)
- Where
- 24 sites in United States, Japan
- Volunteers
- 145 people
- Sponsor
- Microvention-Terumo, Inc.
Cerebral Aneurysm, Stroke
Variability in Transcranial Doppler Technique in Neuro-Critical Care Patients
This study aims to determine the inter- and intra-variability of Transcranial Doppler (TCD) ultrasound in neuro-critical care patients who are planned for consecutive daily TCD evaluations.
- Conditions
- Cerebral Aneurysm, Stroke, Vasospasm, Cerebral, Subarachnoid Hemorrhage, Aneurysmal
- Trial name
- NCT04583163
- Testing
- Transcranial Doppler
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Hackensack Meridian Health
Intracranial Aneurysm, Brain Edema
Goal-Directed Intraoperative Fluid Management Using FloTrac© Monitoring in High-Risk Neurosurgical Patients
This is a prospective, randomized controlled trial to determine if using FloTrac/EV1000 system in neurosurgical patients undergoing craniotomies for aneurysm repair or tumor resection complicated by cerebral edema, or complex…
- Conditions
- Intracranial Aneurysm, Brain Edema, Scoliosis, Surgery
- Trial name
- NCT02701582
- Testing
- Phenylephrine, Epinephrine, Albumin
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- NYU Langone Health
Intracranial Aneurysm
Contour Neurovascular System - European Pre-Market Unruptured Aneurysm
Cerus Endovascular is sponsoring a prospective, multi-center trial to document the safety and performance of the Contour Neurovascular System™ ("Contour").
- Trial name
- CERUS (NCT03680742)
- Testing
- Contour Neurovascular System
- Where
- 6 sites in Austria, Denmark and 1 more
- Volunteers
- 34 people
- Sponsor
- Cerus Endovascular, Inc.
Intracranial Aneurysm
Success in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS)
The Comaneci Embolization Assist Device is indicated for use in the neurovasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm.
- Trial name
- NCT04518670
- Testing
- Comaneci Embolization Assist Device
- Where
- 8 sites in United States
- Volunteers
- 90 people
- Sponsor
- Rapid Medical
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.
Aneurysmal Subarachnoid Hemorrhage
The Effects of Tiopronin on 3-Aminopropanal Level & Neurologic Outcome After Aneurysmal Subarachnoid Hemorrhage
The purpose of this phase II study is to further assess the safety of tiopronin in aneurysmal subarachnoid hemorrhage(aSAH) patients in order to obtain preliminary data on the efficacy of tiopronin versus placebo in reducing…
- Trial name
- NCT01095731
- Testing
- Tiopronin
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- E. Sander Connolly
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 Aneurysms, Seizures
Seizure Prophylaxis in Aneurysm Repair
Seizures are a potential complication of surgical repair of intracranial aneurysms. In order to prevent seizures, many surgeons administer prophylactic anti-epileptic medication during the intra-operative and post-operative…
- Trial name
- NCT01974700
- Testing
- Levetiracetam
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Indiana University
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.
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