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.
Study Type
OBSERVATIONAL
Enrollment
450
Clínica La Sagrada Familia
Buenos Aires, Argentina
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.
Time frame: 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.
Time frame: immediately after treatment, an expected average of 1 hour; to 12 months
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
Time frame: 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).
Time frame: 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
Time frame: during treatment, an expected average of 1 hour
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Ziekenhuis Oost-Limburg
Genk, Belgium
St. Ivan Rilski Hospital
Sofia, Bulgaria
Groupe Hospitalier Pellegrin
Bordeaux, France
Hôpital Pierre Wertheimer
Bron, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
Hôpital Gui de Chauliac (CHU Montpellier)
Montpellier, France
Hôpital Pitié Salpétrière
Paris, France
CHRU Hôpital Maison-Blanche
Reims, France
Hôpital Bretonneau (CHRU de Tours)
Tours, France
...and 16 more locations
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
Time frame: 3-6 and 7-12 months