To assess safety and efficacy of pCONus for the treatment of wide neck bifurcation aneurysms.
Title: pCONus Treatment of Wide Neck Intracranial Aneurysms Acronym: pToWin Device: pCONus Bifurcation Aneurysm Implant Study design: Prospective, multicenter, single-arm clinical investigation Purpose: To assess safety and efficacy of pCONus for the treatment of wide neck bifurcation aneurysms Duration of the study: 48 months Sample size: 100 evaluable 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
116
The device will be introduced through a regular microcatheter. After deployment of the device with the crown positioned in the aneurysm neck the aneurysm will be entered with a microcatheter to perform endovascular coil occlusion. After completion of the coiling procedure the pCONus device will be electrolytically detached from the insertion wire and only the crown and the shaft will remain as a permanent implant.
Clínica La Sagrada Familia Department of Neuroscience (P.L.), Equipo de Neurocirugía Endovascular y Radiología Intervencionista
Buenos Aires, Buenos Aires F.D., Argentina
LKH-Univ. Klinikum Graz Universitätsklinik für Radiologie
Graz, Austria
Hôpital Pierre Wertheimer (HCL Groupement Hospitalier Est)
Bron, France
Effectiveness Aneurysm occlusion (complete or neck remnant)
Time frame: Change from post-procedure to 3-6 and to 7-12 months
Safety Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm
Time frame: within 12 months
Effectiveness
The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of" for each following point: * To place pCONus in the desired location * Correct opening of the device (crown and shaft) * To perform aneurysm occlusion without obliteration of side branches and * To detach the device at the end of the procedure
Time frame: at the time of the procedure
Safety Intra-Procedural Complications
The "Safety Intra-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of" for each following point: * Vessel perforation * Target aneurysm perforation with microcatheter or guidewire * Target aneurysm perforation with pCONus * Target aneurysm perforation with coils * Thromboembolism * Dissection of any access vessel
Time frame: at the time of the procedure
Safety Post-Procedural Complications
The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of" for each following point: * Frequency of new parenchymal hemorrhage during the follow-up period * Frequency of new subarachnoid hemorrhage during the follow-up period * Frequency of new ischemic stroke on follow-up imaging * Rupture of the target aneurysm during the 12 months follow-up period * Rate of in-stent-stenosis * Rate of in-stent-thrombosis
Time frame: Change 1day post procedure up to 12months
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