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.
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arizona
Barrow Neurological Institute
RECRUITING
Phoenix
Colorado
University of Colorado Anschutz
RECRUITING
Aurora
Swedish Medical Research Center
RECRUITING
Englewood
Florida
Baptist Health Research Institute
RECRUITING
Jacksonville
Georgia
Piedmont Atlanta Hospital
RECRUITING
Atlanta
Iowa
University of Iowa
RECRUITING
Iowa City
Illinois
Advocate Lutheran General Hospital
RECRUITING
Park Ridge
Massachusetts
Tufts Medical Center
RECRUITING
Boston
North Carolina
East Carolina University Health Medical Center
RECRUITING
Greenville
New York
UBNS
RECRUITING
Buffalo
North Shore University Hospital - Northwell Health
RECRUITING
Manhasset
Stony Brook University Hospital
RECRUITING
Stony Brook
Oklahoma
The University of Oklahoma
RECRUITING
Oklahoma City
Oregon
Oregon Health & Science University Hospital (OHSU) / Oregon Stroke Center
RECRUITING
Portland
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Washington
University of Washington - Harborview Medical Center
RECRUITING
Seattle
Contact Information
Primary
Mairéad Cleary
mairead.cleary@wallabyphenox.com
+353 91 740 100
Backup
Nguyet T Labenski
nguyet.labenski@wallabyphenox.com
Time Frame
Start Date:2026-03-16
Estimated Completion Date:2032-07
Participants
Target number of participants:214
Treatments
Experimental: Intervention/Treatment
Device: Flow diversion using the p48 MW HPC Device: Flow diversion using the p64 MW HPC