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The purpose of this study is to assess safety and effectiveness of the p64 Flow Modulation Device.
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.
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| 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 |
| 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 |
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Inclusion Criteria
Exclusion Criteria
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The target population for this non-interventional study are patients with ruptured or unruptured aneurysms and segmental diseases in the anterior circulation. Patients can be included in the study if they meet all of the inclusion and none of the exclusion criteria and have provided written informed consent.
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| Name | Affiliation | Role |
|---|---|---|
| Alain Bonafé, Prof. Dr. | Hôpital Gui de Chauliac (CHU de Montpellier), Montpellier, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clínica La Sagrada Familia | Buenos Aires | 1642 | Argentina | |||
| Ziekenhuis Oost-Limburg |
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| Label | URL |
|---|---|
| www.phenox.net | View source |
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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 |
| Genk |
| 3600 |
| Belgium |
| St. Ivan Rilski Hospital | Sofia | 1431 | Bulgaria |
| Groupe Hospitalier Pellegrin | Bordeaux | 33000 | France |
| Hôpital Pierre Wertheimer | Bron | 69500 | France |
| Hôpital Bicêtre | Le Kremlin-Bicêtre | 94275 | France |
| Hôpital Gui de Chauliac (CHU Montpellier) | Montpellier | 34295 | France |
| Hôpital Pitié Salpétrière | Paris | France |
| CHRU Hôpital Maison-Blanche | Reims | France |
| Hôpital Bretonneau (CHRU de Tours) | Tours | 37044 | France |
| Klinikum Augsburg | Augsburg | 86156 | Germany |
| Klinikum Bremen-Mitte | Bremen | 28205 | Germany |
| HELIOS Klinikum Erfurt | Erfurt | Germany |
| Knappschaftskrankenhaus Recklinghausen | Recklinghausen | 45657 | Germany |
| Universitätsklinikum Regensburg | Regensburg | 93053 | Germany |
| Klinikum Stuttgart Katharinenhospital | Stuttgart | 70174 | Germany |
| Ospedale Bellaria Carlo Alberto Pizzardi | Bologna | Italy |
| IRCCS Istituto Clinico Humanitas | Rozzano | 20089 | Italy |
| Regionalny Szpital Specjalistyczny | Grudziądz | 86-300 | Poland |
| Uniwersytecki Szpital Kliniczny we Wroclawiu | Wroclaw | 50-556 | Poland |
| Life Memorial Hospital | Bucharest | 010718 | Romania |
| NSI Burdenko, Moscow | Moscow | Russia |
| Federal Almazov North-West Medical Research Centre | Saint Petersburg | Russia |
| Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| Leeds Teaching Hospitals NHS TRUST | Leeds | LS1 3EX | United Kingdom |
| St George's Hospital | London | SW17 0QT | United Kingdom |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D000783 | Aneurysm |
| D020521 | Stroke |
| D053632 | X-Linked Combined Immunodeficiency Diseases |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016511 | Severe Combined Immunodeficiency |
| D000081207 | Primary Immunodeficiency Diseases |
| D007232 | Infant, Newborn, Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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