New flow diverter device for treating unruptured brain aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU Bordeaux
  Bordeaux, France Recruiting
• Hôpital Bicêtre
  Le Kremlin-Bicêtre, France Recruiting
• CHU de Lyon
  Lyon, France Recruiting
• Helios Klinikum Erfurt
  Erfurt, Germany Recruiting
• Universitätsklinikum Halle (Saale)
  Halle, Germany Recruiting
• Klinikum der LMU München
  München, Germany Recruiting

Study contacts

• Principal investigator: Laurent Pierot, Prof. Dr. — CHRU Hôpital Maison-Blanche
• Study coordinator: Elisabeth Demant-Bauchspiess
• Email: COATING@wallabyphenox.com
• Phone: +49 (0)173 3099117

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Flow Diverter Stent for Intracranial Aneurysm in China

  This study tests a novel flow diverter stent to treat intracranial aneurysms in adults and follows patients through treatment and follow-up.

  Recruiting Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT07821957

• Real-World Experience With the WEB Device for Intracranial Aneurysms

  This study tests how well the Woven EndoBridge device works in routine treatment of intracranial aneurysms in China across multiple centers.

  Recruiting Xuanwu Hospital, Beijing · Beijing · NCT07620626

• Choydar flow-directed mesh stent for unruptured brain aneurysms

  This trial tests the Choydar flow-directed mesh stent to see if it is safe and works for people with unruptured intracranial aneurysms in the internal carotid or vertebral arteries.

  Recruiting at 8 sites Johnson & Johnson Medical (Shanghai) Ltd. · Chenzhou and 7 other locations · NCT07228312

• Pivotal test of the Silk Vista Baby Flow Diverter for unruptured brain aneurysms

  This study tests whether the Silk Vista Baby flow diverter can safely and effectively treat a single unruptured intracranial aneurysm in adults 22–80 years old.

  Recruiting at 6 sites Balt USA · Thousand Oaks, California and 5 other locations · NCT07225075

• Pipeline Vantage post-approval safety and outcomes for intracranial aneurysm treatment

  This project will test whether the Pipeline Vantage embolization device with Shield Technology is safe and effective for adults treated for intracranial aneurysms.

  Recruiting at 10 sites Medtronic Neurovascular Clinical Affairs · Jacksonville, Florida and 9 other locations · NCT06604884

• Improving brain intervention planning using vascular mapping

  This study is testing new ways to plan brain surgeries for aneurysms and AVMs to make them safer and more effective by using advanced mapping and computer models.

  Recruiting University Hospital, Ghent · Ghent · NCT06588543

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.