Actively Recruiting
The Use of p48/64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms
Led by phenox Inc. · Updated on 2026-05-11
214
Participants Needed
13
Research Sites
328 weeks
Total Duration
On this page
Sponsors
P
phenox Inc.
Lead Sponsor
P
Phenox GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Use of p48/64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is 18 years or older
- Modified Rankin Scale score of 2 or less before the procedure
- Has an unruptured or recanalized intracranial aneurysm with saccular or fusiform shape
- Aneurysm located in the internal carotid artery or its branches
- Aneurysm neck is 4 mm or wider or dome-to-neck ratio less than 2
- Parent vessel diameter between 2.0 mm and 5.0 mm both before and after the aneurysm
- Provided written informed consent and agrees to follow study procedures
You will not qualify if you...
- Previous flow diverter or stent in the parent vessel of the target aneurysm
- Any other intracranial aneurysm needing treatment within 3 months after procedure
- Subarachnoid hemorrhage within 30 days before procedure
- True bifurcation aneurysm at vessel branching point
- Unsuitable anatomy due to severe vessel tortuosity, stenosis, or recent carotid stenting
- Brain arteriovenous or other vascular malformation near target aneurysm
- Major surgery in last 30 days or planned in next 90 days
- Unstable neurologic condition worsening in last 30 days
- Serious allergy to contrast agents or device materials
- Irreversible bleeding disorder or active bleeding
- Renal failure with high serum creatinine not on dialysis
- Contraindication to CT, MRI, or angiography
- Allergy or contraindication to anticoagulants or antiplatelets
- Known blood clotting disorder or abnormal blood test values
- Acute life-threatening illness besides neurological disease
- Unable to complete required study follow-ups
- Active infection at time of treatment
- Participation in another conflicting clinical trial
- Women currently pregnant, planning pregnancy, or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
Actively Recruiting
2
University of Colorado Anschutz
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Swedish Medical Research Center
Englewood, Colorado, United States, 80113
Actively Recruiting
4
Baptist Health Research Institute
Jacksonville, Florida, United States, 32207
Actively Recruiting
5
Piedmont Atlanta Hospital
Atlanta, Georgia, United States, 30309
Actively Recruiting
6
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
7
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
8
UBNS
Buffalo, New York, United States, 14203
Actively Recruiting
9
North Shore University Hospital - Northwell Health
Manhasset, New York, United States, 11030
Actively Recruiting
10
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Actively Recruiting
11
The University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
12
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
13
University of Washington - Harborview Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
M
Mairéad Cleary
CONTACT
N
Nguyet T Labenski
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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