Coated Mongolian Aneurysm Treatment Study 1

Vascular Diseases Clinical Trial

— COMATS 1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04305626
• Other study ID #: STUD-192206
• Status: Recruiting
• Start date: June 22, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: October 2021
• Source: Phenox GmbH
• Contact: Hans Henkes, Prof. Dr.
• Phone: +49 711 27834501
• Email: h.henkes[@]klinikum-stuttgart.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 30, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Vascular Diseases

Intervention

Device:
• Endovascular treatment of intracranial aneurysms
Endovascular treatment of intracranial aneurysms with flow diversion.

Locations

Country	Name	City	State
Mongolia	Shastin Central Hospital	Ulaanbaatar	Bayangol District

Sponsors (1)

Lead Sponsor	Collaborator
Phenox GmbH

Country where clinical trial is conducted

Mongolia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Efficacy endpoint	Complete occlusion or the neck remnant of the target aneurysm(s), identified by DSA (Digital subtraction angiography).	12 months after the intervention
Primary	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	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

External Links

•   Initial experience with the novel p64MW HPC flow diverter from a cohort study in unruptured anterior circulation aneurysms under dual antiplatelet medication