NCT03273478

pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Phenox GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess safety and efficacy of pCONUS2 for the treatment of wide neck bifurcation aneurysms.

Detailed description

Title: pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2 Acronym: pToWin2 Device: pCONUS2 Bifurcation Aneurysm Implant Study design: Prospective, multicenter, single-arm clinical investigation Purpose: To assess safety and efficacy of pCONUS2 for the treatment of wide neck bifurcation aneurysms Duration of the study: 30 months Sample size: 100 evaluable patients Number of sites: max. 15 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	Endovascular treatment of bifurcation aneurysm with pCONUS2	Patients suffering from a bifurcation aneurysm will be treated endovascularly with the pCONUS2 device. * The patients do not face any additional risks by participating in the study as the treatment does not differ from the standard of care in any way. * The patients will only be enrolled in the study if they give their written consent. * If they do not wish to participate in the observational study or if they wish to withdraw from it at a later date, they will not have any disadvantages.

Timeline

• Start date: 2018-12-01
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2017-09-06
• Last updated: 2018-04-05