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Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation

NCT04870047•Phenox GmbH

Summary

To assess safety and efficacy of p64 MW HPC Flow Modulation Device under single antiplatelet therapy compared to p64 MW Flow Modulation Device under dual antiplatelet therapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. At least 18 years of age.
•2. Subject has a saccular, unruptured or recanalized intracranial aneurysm. The subject may also have a previous ruptured aneurysm, provided rupture of this aneurysm 30 days from the index procedure.
•3. Subject is intended to be treated for only one target aneurysm during the index procedure except for segmental disease (multiple aneurysms located on the same arterial segment aimed to be treated with one investigational device or investigational telescopic devices).
•4. Subject has already been selected for flow diversion therapy as the appropriate treatment.
•5. Subject has a mRS ≤ 2 before the procedure, as determined by a certified assessor independent of the index procedure.
•6. Subject is able to understand the patient information and provides written informed consent verifying the use of his/her data (according to data protection laws).

Exclusion Criteria

•1. Subject who is currently prescribed under any long lasting antiplatelet and/or anticoagulation medication.
•2. Subject has undergone a surgery including endovascular procedures in the last 30 days prior to the study procedure.
•3. Subject has had an Intracranial hemorrhage and/or subarachnoid hemorrhage in the past 30 days prior to the study procedure.
•4. Subject with target aneurysm previously treated with a stent or flow diverter.
•5. Subject is expected to be treated for another aneurysm during the 30 days following the index procedure.
•6. Subject with a confirmed stenosis in parent artery.
•7. Subject with a blister-like aneurysm, fusiform aneurysm, dissecting aneurysm or aneurysm associated with a brain arteriovenous malformation (AVM).
•8. Subject has a pre-procedure mRS \>2.
•9. Any known contraindication to treatment with the p64 MW HPC Flow Modulation Device in accordance with device IFU.
•10. Subject who has undergone stenting of the ipsilateral carotid artery within 3 months of the index procedure.
+10 more criteria

Locations (18)

CHU Bordeaux

Bordeaux, France

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

CHU de Lyon

Lyon, France

CHU de Montpellier

Montpellier, France

CHU Reims - Hôpital Maison Blanche

Reims, France

Universitätsklinikum Augsburg

Augsburg, Germany

Helios Klinikum Erfurt

Erfurt, Germany

Universitätsklinikum Halle (Saale)

Halle, Germany

Klinikum der LMU München

München, Germany

Klinikum Nürnberg Süd

Nuremberg, Germany

Key Dates

Start Date

September 3, 2021

Primary Completion Date

December 4, 2024

Completion Date

December 1, 2025

Last Updated

June 4, 2025

Enrollment

171

ACTUAL participants

Conditions

Intracranial Aneurysm

Interventions

Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device

DEVICE

Targeting Real World Usage In Stroke Treatment

NCT07474935

Saccular and Fusiform AneurysmsPseudoaneurysm+7 more

View study

RECRUITING

Product Surveillance Registry

NCT01524276

Cardiac Rhythm DisordersUrological Disorders+14 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation

Inclusion Criteria

Exclusion Criteria

Targeting Real World Usage In Stroke Treatment

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