Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
90 participants
OBSERVATIONAL
2019-06-22
2023-12-30
Brief Summary
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Detailed Description
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Purpose: To assess safety and effectiveness of p64 MW HPC or p48 MW HPC under Dual Antiplatelet Medication 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Endovascular treatment of intracranial aneurysms
Endovascular treatment of intracranial aneurysms with flow diversion.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Phenox GmbH
INDUSTRY
Responsible Party
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Locations
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Shastin Central Hospital
Ulaanbaatar, Bayangol District, Mongolia
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Initial experience with the novel p64MW HPC flow diverter from a cohort study in unruptured anterior circulation aneurysms under dual antiplatelet medication
Other Identifiers
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STUD-192206
Identifier Type: -
Identifier Source: org_study_id
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