Coated Mongolian Aneurysm Treatment Study 2 | NCT04305704

Studies
Coated Mongolian Aneurysm Treatment Study 2

NCT04305704

Sponsor

Phenox GmbH

Status

Unknown status

Last Update Posted

Apr 26, 2022Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Intracranial Aneurysm
Aneurysm
Vascular Diseases

Interventions

Not provided

Countries

Mongolia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 8, 2020Actual

Primary Completion Date

Feb 2023Estimated

Completion Date

Dec 30, 2023Estimated

First Submitted Date

Mar 9, 2020

First Submission Date that Met QC Criteria

Mar 9, 2020

First Posted Date

Mar 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2022

Last Update Posted Date

Apr 26, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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 Outcomes

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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Hans Henkes, Prof. Dr.	Contact	+49 711 27834501		h.henkes@klinikum-stuttgart.de
Andrey Petrov, Dr.	Contact			doctorpetrovandrey@gmail.com

Facility	Status	City	State	ZIP	Country	Contacts
Shastin Central Hospital	Recruiting	Ulaanbaatar	Bayangol District	10th khoroolol-2	Mongolia

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

Condition Browse Module

MeSH Terms

ID	Term
D002532	Intracranial Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D001733	Bites and Stings
D020521	Stroke

Ancestor Terms

ID	Term
D020765	Intracranial Arterial Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided