Status:
UNKNOWN
Coated Mongolian Aneurysm Treatment Study 2
Lead Sponsor:
Phenox GmbH
Conditions:
Intracranial Aneurysm
Aneurysm
Eligibility:
All Genders
18-80 years
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 c...
Eligibility Criteria
Inclusion
- At least one unruptured sidewall aneurysm in the anterior circulation
- No implant (e.g., stent) in the target vessel segment
- Age \>18 years and \<80 years
- Not pregnant and in women of childbearing age, on oral contraception for two years following the procedure
- No participation in another trial
- No concomitant disease limiting the life expectancy to \<2 years
- No allergy to non-ionic contrast medium or to ASA and P2Y12 receptor antagonists
- No other neurovascular disorder in the same vascular territory requiring treatment in the foreseeable future
- Ability and willingness to comply with the medication requirements within the study,
- Ability to understand the goal and risks of this study.
Exclusion
- Intracranial aneurysm considered not suitable for FD using p64 MW HPC or p48 MW HPC.
- Aneurysm previously treated with a device in the parent vessel (e.g., stent, flow diverter).
- Another intracranial procedure scheduled for the following 6 months.
- Age \< 18 years and \> 80 years.
- Pregnancy possible or confirmed. Patient not able or willing to arrange contraception for 12 months after treatment.
- Patient not able or willing to adhere to the study protocol.
- Patient not able or willing to undergo the scheduled follow-up examinations.
Key Trial Info
Start Date :
February 8 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04305704
Start Date
February 8 2020
End Date
December 30 2023
Last Update
April 26 2022
Active Locations (1)
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1
Shastin Central Hospital
Ulaanbaatar, Bayangol District, Mongolia, 10th khoroolol-2