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New flow diverter device for treating unruptured brain aneurysms

Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation

Not applicable Interventional Phenox GmbH · NCT04870047

This study is testing a new device for treating unruptured brain aneurysms to see if it works better with one or two types of blood-thinning medications for patients needing this treatment.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment170 (estimated)
Ages18 Years and up
SexAll
SponsorPhenox GmbH Industry-sponsored
Locations21 sites (Bordeaux and 20 other locations)
Trial IDNCT04870047 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of the p64 MW HPC Flow Modulation Device for treating unruptured intracranial aneurysms. Participants will receive either single or dual antiplatelet therapy during the procedure. The study aims to determine which treatment regimen provides better outcomes for patients undergoing flow diversion therapy. Eligible patients will be those who have been selected for this specific type of treatment and meet the inclusion criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a saccular, unruptured or recanalized intracranial aneurysm who are selected for flow diversion therapy.

Not a fit: Patients currently on long-lasting antiplatelet therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with unruptured intracranial aneurysms.

How similar studies have performed: Other studies have explored flow diversion therapy, but the specific approach of using the p64 MW HPC device under different antiplatelet regimens is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.
11. Known serious sensitivity to radiographic contrast agents.
12. Known sensitivity to nickel, titanium metals, or their alloys.
13. Subject already enrolled in other clinical trials (including COATING study) that would interfere with study endpoints.
14. Known renal failure as defined by a serum creatinine \> 2.5 mg/dl (or 220 μmol/l) or glomerular filtration rate (GFR) \< 30.
15. Subject who has a contraindication to MRI or angiography for whatever reason.
16. Subject with a comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
17. Subject with any known allergy to heparin, ASA or other antiplatelet medications.
18. Subject with coagulation disorder
19. Pregnant woman or breast feeding.
20. Adults who lack the capacity to provide informed consent, and all those persons deprived of their liberty in prisons or other places of detention.

Where this trial is running

Bordeaux and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Intracranial Aneurysm
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.