Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-26 @ 11:35 PM
Study NCT ID:
NCT04305704
Status:
UNKNOWN
Last Update Posted:
2022-04-26
First Post:
2020-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coated Mongolian Aneurysm Treatment Study 2
Sponsor:
Phenox GmbH
Organization:
Study Overview
Official Title:
Clinical Evaluation of the p64 MW HPC and the p48 MW HPC Flow Diverters in an Observational Registry
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
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:
COMATS 2
Brief Summary:
The purpose of this study is to assess safety and effectiveness of the p64 MW HPC or p48 MW HPC Flow Modulation Device under prasugrel.
Detailed Description:
Title: Observational Registry With p64 MW HPC in Unruptured Anterior Circulation Aneurysms Under prasugrel
Purpose: To assess safety and effectiveness of p64 MW HPC or p48 MW HPC under prasugrel in consecutive patients with unruptured anterior circulation aneurysms.
Follow-up intervals: Independent follow-ups (after 3 to 6 months and after 12 months and after 24 months) according to site specific standard.
Purpose: To assess safety and effectiveness of p64 MW HPC or p48 MW HPC under prasugrel in consecutive patients with unruptured anterior circulation aneurysms.
Follow-up intervals: Independent follow-ups (after 3 to 6 months and after 12 months and after 24 months) according to site specific standard.
Study Oversight
Has Oversight DMC:
False
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?: