Coated Mongolian Aneurysm Treatment Study 1

Study Overview
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Brief Summary
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The purpose of this study is to assess safety and effectiveness of the p64 MW HPC or p48 MW HPC Flow Modulation Device under Dual Antiplatelet Medication.

Detailed Description
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Title: Observational Registry With p64 MW HPC and p48 MW HPC in Unruptured Anterior Circulation Aneurysms Under Dual Antiplatelet Medication. Purpose: To assess safety and effectiveness of p64 MW HPC or p48 MW HPC under Dual Antiplatelet Medication in consecutive patients with unruptured anterior circulation aneurysms. Follow-up intervals: Independent follow-ups (after 3 to 6 months and after 12 months and after 24 months) according to site specific standard.

Official Title
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Clinical Evaluation of the p64 MW HPC and the p48 MW HPC Flow Diverters in an Observational Registry

Conditions
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Intracranial Aneurysm, Aneurysm, Vascular Diseases

Intervention / Treatment
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* Device: Endovascular treatment of intracranial aneurysms


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least one unruptured sidewall aneurysm in the anterior circulation No implant (e.g., stent) in the target vessel segment Age >18 years and <80 years Not pregnant and in women of childbearing age, on oral contraception for two years following the procedure No participation in another trial No concomitant disease limiting the life expectancy to <2 years No allergy to non-ionic contrast medium or to ASA and P2Y12 receptor antagonists No other neurovascular disorder in the same vascular territory requiring treatment in the foreseeable future Ability and willingness to comply with the medication requirements within the study, Ability to understand the goal and risks of this study. Exclusion Criteria: Intracranial aneurysm considered not suitable for FD using p64 MW HPC or p48 MW HPC. Aneurysm previously treated with a device in the parent vessel (e.g., stent, flow diverter). Another intracranial procedure scheduled for the following 6 months. Age < 18 years and > 80 years. Pregnancy possible or confirmed. Patient not able or willing to arrange contraception for 12 months after treatment. Patient not able or willing to adhere to the study protocol. Patient not able or willing to undergo the scheduled follow-up examinations.

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Endovascular treatment of intracranial aneurysms|Endovascular treatment of intracranial aneurysms with flow diversion.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety endpoint | Occurence of ischemic or hemorrhagic stroke. Incidence of ischemic or hemorrhagic stroke in the territory supplied by the treated artery. | Within 30 days after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety endpoint | Occurence of all adverse events and serious adverse events, related directly or indirectly to the intervention, the used device or the required medication. | Within the first 12 months after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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p64 MW HPC, p48 MW HPC, Flow Diverter, HPC, Dual antiplatelet therapy, Outcome, Occlusion, Stroke