Coated Mongolian Aneurysm Treatment Study 1

• Conditions: Vascular Diseases; Aneurysm; Intracranial Aneurysm

• Registration Number: NCT04305626
• Lead Sponsor: Phenox GmbH

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 Dual Antiplatelet Medication.

Detailed Description

Title: Observational Registry With p64 MW HPC and p48 MW HPC in Unruptured Anterior Circulation Aneurysms Under Dual Antiplatelet Medication.

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.

Study Timeline

• Study Start: 2019-06-22
• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-12
• Status Verified: 2021-10
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-26
• Primary Completion: 2023-06-22
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 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

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety endpoint	Within 30 days after the intervention	Occurence of ischemic or hemorrhagic stroke. Incidence of ischemic or hemorrhagic stroke in the territory supplied by the treated artery.

Secondary Outcome Measures

Name	Time	Method
Safety endpoint	Within the first 12 months after the intervention	Occurence of all adverse events and serious adverse events, related directly or indirectly to the intervention, the used device or the required medication.

Trial Locations

Locations (1)

Shastin Central Hospital; 🇲🇳 Ulaanbaatar, Bayangol District, Mongolia