Using p48/p64 flow‑modulation devices to treat wide‑neck brain aneurysms
p48/64 MW HPC in Aneurysm Occlusion (PIANO): Prospective, Multicenter, Single-arm Clinical Trial to Determine Safety and Effectiveness of the Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms.
This study will try two flow‑diverting devices (p48 MW HPC and p64 MW HPC) in adults with wide‑neck intracranial aneurysms that are unruptured or recanalized.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | phenox Inc. Industry-sponsored |
| Locations | 13 sites (Phoenix, Arizona and 12 other locations) |
| Trial ID | NCT07143019 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with mRS ≤2 who have an unruptured or recanalized saccular or fusiform intracranial aneurysm in the internal carotid artery branches, with neck ≥4 mm or dome‑to‑neck ratio <2 and parent vessel diameter 2.0–5.0 mm, are ideal candidates.
Not a fit: Patients with a subarachnoid hemorrhage within the past 30 days, a prior flow diverter or stent in the parent vessel, or another aneurysm requiring treatment within 3 months are unlikely to benefit from this enrollment.
Why it matters
Potential benefit: If successful, these devices could offer a minimally invasive way to close wide‑neck aneurysms and lower the risk of future rupture with improved device performance.
How similar studies have performed: Flow‑diverter technologies have shown success in treating wide‑neck intracranial aneurysms in prior studies, while the p48/p64 HPC coated devices are newer and are being specifically tested for safety and performance.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Phoenix, Arizona and 12 other locations
- Barrow Neurological Institute — Phoenix, Arizona, 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)
- Piedmont Atlanta Hospital — Atlanta, Georgia, United States (Recruiting)
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
- Tufts Medical Center — Boston, Massachusetts, United States (Recruiting)
- Ubns — Buffalo, New York, United States (Recruiting)
- North Shore University Hospital - Northwell Health — Manhasset, New York, United States (Recruiting)
- Stony Brook University Hospital — Stony Brook, New York, United States (Recruiting)
- The University of Oklahoma — Oklahoma City, Oklahoma, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- University of Washington - Harborview Medical Center — Seattle, Washington, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.