COMATS 2: Coated Mongolian Aneurysm Treatment Study 2

Sponsor

Phenox GmbH (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04305704

Collaborator

(none)

Enrollment

Location

46.7

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Aneurysm Aneurysm Vascular Diseases

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 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 Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Clinical Evaluation of the p64 MW HPC and the p48 MW HPC Flow Diverters in an Observational Registry

Actual Study Start Date :

Feb 8, 2020

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

Efficacy endpoint [12 months after the intervention]
Complete occlusion or the neck remnant of the target aneurysm(s), identified by DSA (Digital subtraction angiography).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.