Coated Mongolian Aneurysm Treatment Study 2 (COMATS 2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Diseases; Aneurysm; Intracranial Aneurysm

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 Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Hans Henkes, Prof. Dr.; Phone Number: +49 711 27834501; Email: h.henkes@klinikum-stuttgart.de
• Study Contact Backup: Name: Andrey Petrov, Dr.; Email: doctorpetrovandrey@gmail.com

Study Locations

• Mongolia
  • Bayangol District
    • Ulaanbaatar, Bayangol District, Mongolia, 10th khoroolol-2
      • Recruiting
      • Shastin Central Hospital
      • Contact: Ganbaatar Rentsenkhuu, Dr.; Email: ganbaatar.neuro@gmail.com
      • Principal Investigator: Ganbaatar Rentsenkhuu, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The target population for this Observational Registry are patients with unruptured intracranial aneurysms suitable for flow diversion on operators' discretion. All patients are tested for the extend of their platelet function inhibition prior treatment using VerifyNow (a point-of-care test).

Patients can be included in the Observational Registry if they meet all of the inclusion and none of the exclusion criteria and have provided written informed consent.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoint	Occurence of ischemic or hemorrhagic stroke. Incidence of ischemic or hemorrhagic stroke in the territory supplied by the treated artery.	Within 30 days after the intervention

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy endpoint	Complete occlusion or the neck remnant of the target aneurysm(s), identified by DSA (Digital subtraction angiography).	12 months after the intervention

Collaborators and Investigators

• Sponsor: Phenox GmbH

Publications and helpful links

Helpful Links

• Early clinical experience with the p48MW HPC and p64MW HPC flow diverters in the anterior circulation aneurysm using single anti-platelet treatment

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2020
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 12, 2020

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Stroke; Occlusion; Outcome; p64 MW HPC; p48 MW HPC; Flow Diverter; HPC
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Vascular Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: STUD-192207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No