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To assess safety and efficacy of p64 MW HPC Flow Modulation Device under single antiplatelet therapy compared to p64 MW Flow Modulation Device under dual antiplatelet therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| p64 MW HPC Flow Diverter + SAPT | Experimental |
| |
| p64 MW Flow Diverter + DAPT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device | Device | Patients suffering from a distal intracranial aneurysm will be treated endovascularly with the p64 MW HPC Flow Modulation Device. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of DWI lesions | Number of diffusion-weighted imaging (DWI) lesions within 48 hours (+/- 24 hours) of the index procedure visualized via MRI. | 48 hours (± 24 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Short-term morbi-mortality rate | Morbi-mortality rate at 30 days assessed by mRS > 2 | 30 days (± 7 days) |
| Rate of neurological death or major stroke | Rate of neurological death or major stroke (ischemic or hemorrhagic, defined as an increase of 4 or more points according to the National Institute of Health Stroke Scale Score) in the territory supplied by the treated artery, as assessed by the Clinical Events Committee |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Pierot, Prof. Dr. | CHRU Hôpital Maison-Blanche | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux | Bordeaux | 33076 | France | |||
| Hôpital Bicêtre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38391195 | Derived | Ramirez-Velandia F, Enriquez-Marulanda A, Filo J, Young M, Fodor TB, Sconzo D, Muram S, Granstein JH, Shutran M, Taussky P, Ogilvy CS. Comparison of Thromboembolic Events Between Pipeline Embolization Device (PED) Shield and PED/PED Flex: A Propensity Score-Matched Analysis. Neurosurgery. 2024 Aug 1;95(2):330-338. doi: 10.1227/neu.0000000000002883. Epub 2024 Feb 23. | |
| 35609974 |
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| 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure |
| Long-term morbi-mortality rate | Rate of subjects who have a mRS decline to a score of 3 or more (mRS > 3), or an increase of 2 points from baseline mRS score, as assessed by the Clinical Events Committee | 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure |
| Rate of subjects with dissusion-weighted imaging (DWI) lesions | Rate of subjects with greater than 6 diffusion-weighted imaging (DWI) lesions or territorial stroke | 48 hours (± 24 hours) |
| Delayed aneurysm rupture | Rate of an intracranial hemorrhage from delayed aneurysm rupture (from the day after index procedure), as assessed by the Clinical Events Committee | 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure |
| Delayed intraparenchymal hemorrhage | Rate of delayed intraparenchymal haemorrhage unrelated to aneurysm rupture, as assessed by the Clinical Events Committee | 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure |
| Rate of peripheral bleeding | Rate of peripheral bleeding, as assessed by the Clinical Events Committee | Any event reported from discharge to 365 days (335 - 456 days) post procedure |
| Rate of device deployment at the target site without technical complications | Rate of device deployment at the target site without technical complications, as assessed by the site | During intervention |
| Rate of complete aneurysm occlusion | Rate of complete aneurysm occlusion using the 3-grade scale, as assessed by the Core Lab | 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure |
| Rate of target aneurysm recurrence | Rate of target aneurysm recurrence, as assessed by the Imaging Core Lab | 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure |
| Rate of target aneurysm retreatment | Rate of target aneurysm retreatment, as assessed by the Clinical Event Committee | 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure |
| Rate of intrastent stenosis and/or thrombosis at the target site | Rate of intrastent stenosis and/or thrombosis at the target site, as assessed by the Core Lab through DSA | 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure |
| Mean length of hospital stay | Mean length of hospital stay (from hospital admission and up to hospital discharge) | From admission up to discharge, assessed up to 456 days |
| Le Kremlin-Bicêtre |
| 94270 |
| France |
| CHU de Lyon | Lyon | 69002 | France |
| CHU de Montpellier | Montpellier | 34090 | France |
| CHU Reims - Hôpital Maison Blanche | Reims | 51092 | France |
| Universitätsklinikum Augsburg | Augsburg | 86156 | Germany |
| Helios Klinikum Erfurt | Erfurt | 99089 | Germany |
| Universitätsklinikum Halle (Saale) | Halle | 06120 | Germany |
| Klinikum der LMU München | München | 81377 | Germany |
| Klinikum Nürnberg Süd | Nuremberg | 90471 | Germany |
| Klinikum Vest Recklinghausen | Recklinghausen | Germany |
| Klinikum Stuttgart | Stuttgart | 70174 | Germany |
| Hadassah University Medical Center | Jerusalem | 9112001 | Israel |
| Fondazione I.R.C.C.S. Instituto Neurologico Carlo Besta | Milan | 20133 | Italy |
| UNLP Košice | Košice | 04190 | Slovakia |
| Universitätsspital Basel | Basel | 4051 | Switzerland |
| Queen Elisabeth Hospital Birmingham | Birmingham | B15 2GW | United Kingdom |
| Western General Hospital | Edinburgh | United Kingdom |
| Pierot L, Lamin S, Barreau X, Berlis A, Ciceri E, Cohen JE, Costalat V, Eker OF, Henkes H, Holtmannspotter M, Januel AC, Keston P, Klisch J, Psychogios MN, Valvassori L, Cognard C, Spelle L. Coating (Coating to Optimize Aneurysm Treatment in the New Flow Diverter Generation) study. The first randomized controlled trial evaluating a coated flow diverter (p64 MW HPC): study design. J Neurointerv Surg. 2023 Jul;15(7):684-688. doi: 10.1136/neurintsurg-2022-018969. Epub 2022 May 24. |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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