The Use of p48/64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms

Conditions

• Aneurysm, Intracranial
• Brain Aneurysm
• Fusiform Aneurysm
• Hemorrhagic Stroke
• Saccular Aneurysm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Flow diversion — DEVICE
  The p48 MW HPC and p64 MW HPC Flow Modulation Device is indicated for use in the treatment of intracranial aneurysms (IAs) arising from a parent vessel with a diameter of ≥2.0mm and ≤5.0 mm.

Study Details

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.

Key Dates

Start date

Mar 16, 2026

Status verified

Apr 2026

Primary completion

Jul 31, 2027

Completion

Jul 31, 2032

Study Design

Enrollment

214 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Intervention/Treatment
  Device: Flow diversion using the p48 MW HPC Device: Flow diversion using the p64 MW HPC

Primary Outcome Measure

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. [ Time Frame: 12 months ]

Central Contacts

• Mairéad Cleary
  +353 91 740 100
  [email protected]
• Nguyet T Labenski
  [email protected]

Locations (17)

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