Coated Mongolian Aneurysm Treatment Study 2 (COMATS 2)

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Status: Unknown

Conditions: Aneurysm; Intracranial Aneurysm; Vascular Diseases

Study type: Observational

Funder types: Industry

Identifiers

NCT04305704

STUD-192207

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.