Last updated: April 19, 2022
Sponsor: Phenox GmbH
Overall Status: Active - Recruiting
Phase
N/A
Condition
Aneurysm
Vascular Diseases
Treatment
N/AClinical Study ID
NCT04305626
STUD-192206
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 yearsfollowing 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 inthe 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
Exclusion Criteria:
- 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, flowdiverter).
- 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 contraceptionfor 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.
Study Design
Total Participants: 90
Study Start date:
June 22, 2019
Estimated Completion Date:
December 30, 2023
Study Description
Connect with a study center
Shastin Central Hospital
Ulaanbaatar, Bayangol District 10th khoroolol-2
MongoliaActive - Recruiting
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