Ignite Creation Date:
2024-05-06 @ 10:31 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03273478
Status:
UNKNOWN
Last Update Posted:
2018-04-05
First Post:
2017-08-23
Brief Title:
pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2
Sponsor:
Phenox GmbH
Organization:
Phenox GmbH
Study Overview
Official Title:
pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2
Status:
UNKNOWN
Status Verified Date:
2018-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
pToWin2
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None