Status:
RECRUITING
The Use of p48/64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms
Lead Sponsor:
phenox Inc.
Collaborating Sponsors:
Phenox GmbH
Conditions:
Hemorrhagic Stroke
Aneurysm, Intracranial
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To determine safety and effectiveness of the p48 MW HPC and p64 MW HPC flow diverter in the treatment of wide-necked intracranial aneurysms.
Detailed Description
To assess safety, effectiveness, and performance of the p48/p64 MW HPC flow diverter in the endovascular treatment of wide-necked intracranial aneurysms (IA) at 12 months post-procedure.
Eligibility Criteria
Inclusion
- 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
- 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
- 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)
- Known serious sensitivity to radiographic contrast agents that cannot be managed medically
- Known sensitivity to nickel, titanium metals or their alloys or any other investigational device components
- Irreversible bleeding disorder and/or signs of active bleeding at subject presentation
- Known renal failure with a serum creatinine \>2.5 mg/dl (or 220 μmol/l) not on dialysis
- Contraindication to CT scan, MRI, or angiography
- Contraindication or known allergies to anticoagulants or antiplatelets (e.g. aspirin, heparin, clopidogrel, prasugrel, or ticagrelor)
- Known coagulopathy, or an admission International Normalized Ratio \>3.0 without oral anticoagulation therapy, or an admission platelet count of \<100000
- Has acute life-threatening illness other than the neurological disease (i.e., acute kidney or heart failure) to be treated in this trial
- Unable to complete the required study follow-ups
- Evidence of active infection at the time of treatment (e.g., fever, elevated white blood cell count)
- Participating in another clinical trial that could affect participation or primary outcomes of this study
- Women currently pregnant or wish to become pregnant during the study or breast feeding.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2032
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT07143019
Start Date
December 1 2025
End Date
May 1 2032
Last Update
December 10 2025
Active Locations (1)
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1
UBNS
Buffalo, New York, United States, 14203