Coated Mongolian Aneurysm Treatment Study 2

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04305704

Acronym

COMATS 2

Enrollment

Registered

2020-03-12

Start date

2020-02-08

Completion date

2023-12-30

Last updated

2022-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysm, Intracranial Aneurysm, Vascular Diseases

Keywords

p64 MW HPC, p48 MW HPC, Flow Diverter, HPC, Outcome, Occlusion, Stroke

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

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

Countries

Mongolia

Contacts

Primary ContactHans Henkes, Prof. Dr.

h.henkes@klinikum-stuttgart.de+49 711 27834501

Backup ContactAndrey Petrov, Dr.

doctorpetrovandrey@gmail.com

Outcome results