Pilot Study of the Contour Neurovascular SystemTM

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study of the Contour Neurovascular SystemTM

Conditions
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Intracranial Aneurysm

Intervention / Treatment
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* Device: Contour Neurovascular System placement


Participation Criteria
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Eligibility Criteria
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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 Known allergy to platinum, nickel or titanium Known allergy to contrast agents Stenosis of the target IA's parent vessel >50% Taking daily aspirin or other platelet inhibitor (clopidogrel or equivalent) other than for the target aneurysm Taking any anticoagulants (e.g., warfarin) Abnormal clotting parameters Pregnant, breastfeeding or planning pregnancy in the next 2 years Other medical conditions that could increase the risk of neurovascular procedures (e.g., liver failure, cancer, etc.) or ability to comply with study requirements Participating in another study with investigational devices or drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contour Neurovascular System placement<br>Treatment of intracranial aneurysm with the Contour Neurovascular System device. | Device: Contour Neurovascular System placement<br>* Patients who meet the eligibility criteria will have their target aneurysm treated with the Contour Neurovascular System device via standard endovascular procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Major Ipsilateral Stroke/SAH or Death Due to Neurologic Cause Within Six (6) Months After Treatment. | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusion Status of the Target IA | Last known occlusion status of the target IA as judged by an independent core laboratory using the Raymond-Roy occlusion scale (Class 1 - Complete occlusion; Class 2 - Residual neck; Class 3 - Residual aneurysm). | 6 months (3 patients), 1 year (14 patients), 2 year (2 patients) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain, Intracranial Aneurysm Treatment, Endovascular Treatment, Brain Aneurysm, Neurovascular diseases, Aneurysms, Cerebrovascular Disorders, Central Nervous System Diseases, Vascular diseases