Pilot Study of the Contour Neurovascular SystemTM
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracranial Aneurysm
- Sponsor
- Cerus Endovascular, Ltd
- Enrollment
- 20
- Primary Endpoint
- Percentage of Subjects With Major Ipsilateral Stroke/SAH or Death Due to Neurologic Cause Within Six (6) Months After Treatment.
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
Prospective, single arm, multi centre study to evaluate the safety and performance of the Contour Neurovascular SystemTM in the treatment of intracranial aneurysm (IA)
Detailed Description
Prospective, single-arm, multi-centre European study to evaluate the safety and performance of the Contour Neurovascular SystemTM in the treatment of intracranial aneurysm (IA). Target aneurysms are unruptured aneurysms requiring endovascular treatment in the anterior and posterior cerebral circulation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18-80 years at screening
- •Unruptured saccular IA in the anterior or posterior circulation with dimensions consistent with Table 2
- •IA appears suitable for Contour Neurovascular SystemTM device Patient has the necessary mental capacity to participate and is willing and able to participate in the study for the duration of the study follow-up and is able to comply with study requirements Patient able to understand and sign a study-specific informed consent form
Exclusion Criteria
- •Ruptured IA
- •Any other IA that requires treatment in the next year
- •IA width \>8.5 or \<2 mm
- •IA neck \>8 or \<2 mm
- •IA minimum height \<4mm
- •IA embolisation would most likely cause stroke
- •Target IA contains other devices/implants (e.g., coils)
- •Inability to access the target IA with the microcatheter
- •Any congenital or iatrogenic coagulopathy
- •Platelet count \<50,000/microliter
Outcomes
Primary Outcomes
Percentage of Subjects With Major Ipsilateral Stroke/SAH or Death Due to Neurologic Cause Within Six (6) Months After Treatment.
Time Frame: 6 months
Percentage of subjects with major ipsilateral stroke/SAH or death due to neurologic cause within six (6) months after treatment. All neurological events were adjudicated by an independent Medical Monitor.
Secondary Outcomes
- Occlusion Status of the Target IA(6 months (3 patients), 1 year (14 patients), 2 year (2 patients))