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This study has not been started. The Sponsor has decided not to pursue this study.
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Cerus Endovascular is sponsoring a prospective, multi-center PMCF to document the safety and performance of the Contour Neurovascular Systemâ„¢ (hereinafter "Contour") in normal medical use.
The primary objective of this study is to document the safety and performance of the "Contour Neurovascular Systemâ„¢. The data from the study will be reported as a Post Market study to the Notified Body as part of the Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF) plan.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contour Neurovascular System | Device | Intrasaccular flow disruptor/divertor |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with non-accidental death cause or any major ipsilateral stroke within the first 30 days after treatment or major ipsilateral stroke or death due to neurological cause from day 31 to final follow-up visit per standard of care). | Primary Safety Endpoint | 1 year |
| Aneurysm occlusion rate on the follow-up angiogram as reported by the investigator." "Success will be defined as complete occlusion demonstrated by a Grade 1 using the Raymond Roy (RR) Scale. | Primary Performance Endpoint | 1 year |
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Inclusion Criteria:
1. Patient indicated for treatment of a single, unruptured aneurysm is according to the national/international guidelines.
2. Age 18 years or older at screening. 3. Patient suitable for non-emergency endovascular embolization of saccular IAs.
4. IA located at a bifurcation in the anterior or posterior circulation with dimensions consistent with implant size selection guidelines included in the IFU for Contour.
5. 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.
6. Patient is able to give their informed consent. This must be demonstrated by means of a personally signed and dated informed consent document indicating that the subject has been informed of and understood all pertinent aspects of the study.
Exclusion Criteria
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Patients with enraptured bifurcated intracranial aneurysms.
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |