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.
phenox Inc.
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.
Description
To assess safety, effectiveness, and performance of the p48/p64 MW HPC Flow Modulation Device in the endovascular treatment of wide-necked intracranial aneurysms (IA) at 12 months post-procedure.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 th…
Interventions
- DeviceFlow diversion
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.
Locations (11)
- Barrow Neurological InstitutePhoenix, Arizona
- University of Colorado AnschutzAurora, Colorado
- Swedish Medical Research CenterEnglewood, Colorado
- Baptist Health Research InstituteJacksonville, Florida
- Tufts Medical CenterBoston, Massachusetts
- UBNSBuffalo, New York