Using p48/p64 flow‑modulation devices to treat wide‑neck 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

Participants will undergo endovascular placement of the p48 MW HPC or p64 MW HPC flow modulation device to divert blood flow away from wide‑neck intracranial aneurysms located in the internal carotid artery and its branches. Eligible aneurysms are saccular or fusiform with a neck ≥4 mm or a dome‑to‑neck ratio <2 and parent vessel diameter between 2.0 and 5.0 mm. Safety, device performance, and aneurysm occlusion are followed with clinical and imaging assessments through 12 months after the procedure. Subjects with recent subarachnoid hemorrhage, prior flow diverters in the target vessel, or other aneurysms needing treatment within 3 months are excluded.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject is ≥ 18 years
2. Subject has a mRS ≤2 before the index procedure
3. Subject has an unruptured or recanalized intracranial aneurysm (IA). The subject may also have a previous ruptured aneurysm, provided rupture of this aneurysm has occurred more than 30 days from the index procedure. The IA must have the following characteristics below:

   1. Saccular or fusiform morphology
   2. Located in the internal carotid artery and its branches
   3. Aneurysm neck ≥4 mm or dome-to-neck ratio \<2
   4. Parent vessel diameter ≥2.0mm and ≤5.0mm both distal and proximal to the target IA
4. Subject or subject's legally authorized representative (LAR) has provided written informed consent and has agreed to comply with study procedures.

Exclusion Criteria:

1. Previous flow diverter or stent within the parent vessel of the target aneurysm to be treated
2. Any other known IA requiring treatment within 3 months post-procedure
3. Subarachnoid hemorrhage in the past 30 days prior to the index procedure
4. Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at the point of vessel bifurcation
5. Anatomy unsuitable for endovascular procedure due to severe vessel tortuosity or stenosis, or stented ipsilateral carotid artery within 3 months prior to the index procedure
6. Subject with a brain arteriovenous malformation (AVM) or other vascular malformation in the area of the target aneurysm
7. Major surgery in the last 30 days, including endovascular procedures, or is planned in the next 90 days after enrollment date
8. Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days)
9. Known serious sensitivity to radiographic contrast agents that cannot be managed medically
10. Known sensitivity to nickel, titanium metals or their alloys or any other investigational device components
11. Irreversible bleeding disorder and/or signs of active bleeding at subject presentation
12. Known renal failure with a serum creatinine \>2.5 mg/dl (or 220 μmol/l) not on dialysis
13. Contraindication to CT scan, MRI, or angiography
14. Contraindication or known allergies to anticoagulants or antiplatelets (e.g. aspirin, heparin, clopidogrel, prasugrel, or ticagrelor)
15. Known coagulopathy, or an admission International Normalized Ratio \>3.0 without oral anticoagulation therapy, or an admission platelet count of \<100000
16. Has acute life-threatening illness other than the neurological disease (i.e., acute kidney or heart failure) to be treated in this trial
17. Unable to complete the required study follow-ups
18. Evidence of active infection at the time of treatment (e.g., fever, elevated white blood cell count)
19. Participating in another clinical trial that could affect participation or primary outcomes of this study
20. Women currently pregnant or wish to become pregnant during the study or breast feeding.

Where it's running

• Barrow Neurological Institute
  Phoenix, Arizona, United States Recruiting
• University of Southern California Health Sciences / Keck Hospital of USC
  Los Angeles, California, United States Recruiting
• UCSF Medical Center
  San Francisco, California, United States Recruiting
• University of Colorado Anschutz
  Aurora, Colorado, United States Recruiting
• Swedish Medical Research Center
  Englewood, Colorado, United States Recruiting
• Baptist Health Research Institute
  Jacksonville, Florida, United States Recruiting

Study contacts

• Principal investigator: Demetrius Lopes, MD — Advocate Aurora Research Institute, LLC
• Study coordinator: Mairéad Cleary
• Email: mairead.cleary@wallabyphenox.com
• Phone: +353 91 740 100

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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.