Clinical trial NCT04305626: Coated Mongolian Aneurysm Treatment Study 1
Official title: Clinical Evaluation of the p64 MW HPC and the p48 MW HPC Flow Diverters in an Observational Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Aneurysm
Aneurysm
Vascular Diseases
Keywords: p64 MW HPC
p48 MW HPC
Flow Diverter
HPC
Dual antiplatelet therapy
Outcome
Occlusion
Stroke
Lead sponsor: Phenox GmbH
Sponsor class: INDUSTRY
First posted: 2020-03-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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. 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.

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 Dual Antiplatelet Medication.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety endpoint
timeFrame: Within 30 days after the intervention
Secondary outcomes:
measure: Safety endpoint
timeFrame: Within the first 12 months after the intervention
Other outcomes:
measure: Efficacy endpoint
timeFrame: 12 months after the intervention
Locations:
city: Ulaanbaatar
country: Mongolia
facility: Shastin Central Hospital
state: Bayangol District
Study officials:
References: