NCT02554708

pCONus Treatment of Wide Neck Intracranial Aneurysms

pToWin pCONus Treatment of Wide Neck Intracranial Aneurysms

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 116 (actual)
• Sponsor: Phenox GmbH · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To assess safety and efficacy of pCONus for the treatment of wide neck bifurcation aneurysms.

Detailed description

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

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	implantation of the pCONus Bifurcation Aneurysm Implant	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.

Timeline

• Start date: 2015-08-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2015-09-18
• Last updated: 2022-09-29

Locations

10 sites across 5 countries: Argentina, Austria, France, Germany, Italy