Coated Mongolian Aneurysm Treatment Study 2

NCT04305704 | Unknown

• 1 other identifier: STUD-192207
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Aneurysm; Aneurysm; Vascular Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety endpoint

  Within the first 12 months after the intervention

Other Outcomes (1)

• Efficacy endpoint

  12 months after the intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Phenox GmbH: lead

Study Sites (1)

Shastin Central Hospital

Ulaanbaatar, Bayangol District, 10th khoroolol-2, Mongolia

RECRUITING

Related Links

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

MeSH Terms

Conditions

Intracranial Aneurysm; Aneurysm; Vascular Diseases; Bites and Stings; Stroke

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Central Study Contacts

Hans Henkes, Prof. Dr.

CONTACT

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

Andrey Petrov, Dr.

CONTACT

doctorpetrovandrey@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 12, 2020
• Study Start: February 8, 2020
• Primary Completion: February 1, 2023
• Study Completion: December 30, 2023
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)