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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
171
Patients suffering from a distal intracranial aneurysm will be treated endovascularly with the p64 MW HPC Flow Modulation Device.
CHU Bordeaux
Bordeaux, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
CHU de Lyon
Number of DWI lesions
Number of diffusion-weighted imaging (DWI) lesions within 48 hours (+/- 24 hours) of the index procedure visualized via MRI.
Time frame: 48 hours (± 24 hours)
Short-term morbi-mortality rate
Morbi-mortality rate at 30 days assessed by mRS \> 2
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Lyon, France
CHU de Montpellier
Montpellier, France
CHU Reims - Hôpital Maison Blanche
Reims, France
Universitätsklinikum Augsburg
Augsburg, Germany
Helios Klinikum Erfurt
Erfurt, Germany
Universitätsklinikum Halle (Saale)
Halle, Germany
Klinikum der LMU München
München, Germany
Klinikum Nürnberg Süd
Nuremberg, Germany
...and 8 more locations
Delayed intraparenchymal hemorrhage
Rate of delayed intraparenchymal haemorrhage unrelated to aneurysm rupture, as assessed by the Clinical Events Committee
Time frame: 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
Time frame: 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
Time frame: During intervention
Rate of complete aneurysm occlusion
Rate of complete aneurysm occlusion using the 3-grade scale, as assessed by the Core Lab
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: From admission up to discharge, assessed up to 456 days