Diversion-p64 Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device

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 Flow Modulation Device.

Detailed Description
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Title: Diversion-p64. Device: p64 Flow Modulation Device. Study design: Prospective, multicenter, single arm Post Market Clinical Follow-Up Study. Purpose: To assess safety and effectiveness of p64. Study duration: 48 months. Sample Size: 400 patients. Number of sites: > 20. Follow-up intervals: Two independent follow-ups (after 3-6 and 7-12 months) according to site specific standard.

Official Title
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Prospective, Multicenter, Single Arm Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device

Conditions
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Intracranial Aneurysm

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Age ≥ 18 Patient harbours either one saccular or one dissecting or one blisterlike or one fusiform intracerebral aneurysm or one intracerebral segmental disease, in the anterior circulation for which the indication for p64 treatment is given Patient or legal representative provides written informed consent verifying that he/she consents to the use of his/her data (according to the data protection laws) Exclusion Criteria Aneurysms of the posterior circulation Imaging evidence of bifurcation aneurysms Imaging evidence of dissections Imaging evidence of fistulae Imaging evidence of arteriovenous malformations Patient is harbouring another aneurysm that has to be treated within six months after first procedure Known allergy to study medication, e.g. ASA, Clopidogrel, Heparin or contrast media Confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication) Current involvement in another study or trial Parent vessel treated with other Flow Diverters than p64 during intervention and re-treatment

Ages Eligible for Study
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Minimum Age: 18 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the rate of complete occlusion | Rate of complete aneurysm occlusion is assessed immediately after treatment (an expected average of 1 hour) and at both follow-up visits (3-6 months and 7-12 months). The change is assesed. | immediately after treatment, an expected average of 1 hour; to 12 months | 
| Change of frequency of major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm | Frequency of major stroke (ischemic or hemorrhagic) or neurological death is assessed immediately after treatment (an expected average of 1 hour) and at both follow-up visits (3-6 months and 7-12 months). The change is assesed. | immediately after treatment, an expected average of 1 hour; to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-procedural technical complications | p64 placed in the desired location Correct opening of p64 (markers fully deployed) at the end of the procedure Ability to detach p64 at the end of the procedure | during treatment, an expected average of 1 hour | 
| Change of Angiographic results | Change in both Rate of re-growth (related rate of re-treatment) and Rate of recanalization (related rate of re-treatment) are assessed immediately after treatment (an expected average of 1 hour) and at both follow-up visits (3-6 months and 7-12 months). | immediately after treatment, an expected average of 1 hour; to 12 months | 
| Intra-procedural vascular complications | Vessel perforation (e.g. with distal wire tip of p64, microcatheter) Target aneurysm perforation (e.g. with distal wire tip of p64, microcatheter) Thromboembolism Dissection of any access vessel Side branch occlusion | during treatment, an expected average of 1 hour | 
| Post-procedural Complications | Parenchymal hemorrhage detected during the follow-up period Subarachnoid hemorrhage detected during the follow-up period Ischemic stroke detected on follow-up imaging Rupture of the target aneurysm detected during the follow-up period Rate of in-stent-stenosis detected during the follow-up period | 3-6 and 7-12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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p64, Aneurysm, intracerebral, stroke