The Use of p48/64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneu… (NCT07143019) | Clinical Trial Compass
RecruitingNot Applicable
The Use of p48/64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms
United States214 participantsStarted 2026-03-16
Plain-language summary
To determine safety and effectiveness of the p48 MW HPC and p64 MW HPC Flow Modulation Device in the treatment of wide-necked intracranial aneurysms.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject is ≥ 18 years
✓. Subject has a mRS ≤2 before the index procedure
✓. 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:
✓. Saccular or fusiform morphology
✓. Located in the internal carotid artery and its branches
✓. Aneurysm neck ≥4 mm or dome-to-neck ratio \<2
✓. Parent vessel diameter ≥2.0mm and ≤5.0mm both distal and proximal to the target IA
✓. Subject or subject's legally authorized representative (LAR) has provided written informed consent and has agreed to comply with study procedures.
Exclusion criteria
✕. Previous flow diverter or stent within the parent vessel of the target aneurysm to be treated
✕. Any other known IA requiring treatment within 3 months post-procedure
✕. Subarachnoid hemorrhage in the past 30 days prior to the index procedure
✕. Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at the point of vessel bifurcation
What they're measuring
1
Primary Efficacy and Performance Endpoint: Number of subjects with 100% occlusion of the target aneurysm without significant parent artery stenosis and no retreatment of the target aneurysm from the index procedure to the 12-month follow-up visit.
Timeframe: 12 months
2
The Primary Safety Endpoint: Number of subjects with ischemic or hemorrhagic stroke or neurologic death from treatment to 12-months, as adjudicated by a Clinical Events Committee.
. 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
✕. Subject with a brain arteriovenous malformation (AVM) or other vascular malformation in the area of the target aneurysm
✕. Major surgery in the last 30 days, including endovascular procedures, or is planned in the next 90 days after enrollment date
✕. Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days)