US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair
NCT04852783 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2026-03-31
Summary
The purpose of this trial is to gather data on the safety and effectiveness of the Contour /Contour 021 System in the treatment of wide-necked bifurcated saccular, intracranial aneurysms for submission to FDA in support of a premarket approval application for the device.
Conditions
- Aneurysm, Intracranial
Interventions
- DEVICE
-
Contour Neurovascular System
Endovascular embolization of wide-necked, bifurcated saccular intracranial aneurysms.
Sponsors & Collaborators
-
Cerus Endovascular, Inc.
lead INDUSTRY
Principal Investigators
-
Pascal M Jabbour, MD · Jefferson University Hospitals
-
Demetrius Lopes, MD · Advocate Medical Group - Brain and Spine Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-08-06
- Primary Completion
- 2026-02-20
- Completion
- 2030-02-28
- FDA Device
- Yes
Countries
- United States
Study Locations
More Related Trials
-
MRI-markers to Monitor Small Vessel Disease Dynamics in the Prognosis of Small Vessel Disease-associated, Cerebrovascular Events
NCT05773235 ·Status: UNKNOWN
-
A Study to Evaluate the Use of an Indwelling Catheter to Obtain Cerebrospinal Fluid (CSF) by Low-rate Continuous Sampling (MK-0000-211)
NCT01325662 ·Status: COMPLETED
-
Magnetic Resonance Imaging for the Study of Patients With Neurological Disorders
NCT00001362 ·Status: COMPLETED
-
Optic Nerve Ultrasound in Severe Traumatic Injury
NCT02618226 ·Status: COMPLETED
-
Contrast-enhanced Ultrasound (CE-US) and Magnetic Resonance Imaging (MRI): Evaluating Plaque Neovascularisation
NCT00677963 ·Status: COMPLETED ·Phase: NA
-
Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries
NCT02959294 ·Status: WITHDRAWN ·Phase: EARLY_PHASE1
-
Development of a Database to Investigate Digital and Blood-Based Biomarkers and Their Relationship to Tau and Amyloid PET Imaging in Older Participants Who Are Cognitively Normal (CN), Have Mild Cognitive Impairment (MCI), or Have Mild-to-Moderate AD Dementia
NCT06584357 ·Status: RECRUITING
-
IGF and Other Neurotrophic Factors in Patients With Dementia
NCT02271750 ·Status: COMPLETED
-
Eye to Brain Connection
NCT05215782 ·Status: COMPLETED
-
Venous Obstruction in Neurodegenerative Disorders Research Registry
NCT01593358 ·Status: UNKNOWN
-
Biomarkers in Concussion
NCT05943561 ·Status: UNKNOWN
-
TRACK-TBI Longitudinal Biomarker Study
NCT05201833 ·Status: ACTIVE_NOT_RECRUITING
-
Blood-Brain-Barrier Opening Using Focused Ultrasound With IV Contrast Agents in Patients With Early Alzheimer's Disease
NCT02986932 ·Status: COMPLETED ·Phase: NA
-
Intraoperative Fluorescence With Augmented Reality
NCT03888014 ·Status: COMPLETED
-
Stepped-Wedge Cluster Randomized Trial of AI-Assisted CTA Detection for Intracranial Aneurysms in Regional Hospitals
NCT07124624 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Cerebrovascular Reactivity and Oxygen Metabolism as Markers of Neurodegeneration After Traumatic Brain Injury
NCT04820881 ·Status: UNKNOWN
-
Perfusion MRI in Reversible Cerebral Vasoconstriction Syndrome
NCT02756416 ·Status: UNKNOWN ·Phase: NA
-
4D FLOW: Feasibility Study of a Sequence 4D of Flow Applied to the Cervico-encephalic Vascular Pathologies
NCT02602951 ·Status: COMPLETED ·Phase: NA
-
Imaging Studies in Corticobasal Syndrome
NCT07000851 ·Status: RECRUITING
-
4 Repeat Tauopathy Neuroimaging Initiative
NCT01804452 ·Status: COMPLETED
-
Transforming Research and Clinical Knowledge in Traumatic Brain Injury
NCT02119182 ·Status: COMPLETED
-
Evaluation of DeltaMaxx® Microcoil System in Intracranial Aneurysms
NCT01945827 ·Status: WITHDRAWN
-
National Database of the Virtual Institute of Cerebrovascular Diseases
NCT05925699 ·Status: NOT_YET_RECRUITING
-
Technical Development of Multi-Parametric Renocerebral MRI
NCT02831335 ·Status: RECRUITING
-
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral Beta-Amyloid When Compared With Postmortem Histopathology
NCT01886820 ·Status: UNKNOWN ·Phase: PHASE3