An interventional study of Flow diversion in Hemorrhagic Stroke, Aneurysm, Intracranial and Saccular Aneurysm, sponsored by phenox Inc.. Recruiting at 25 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by phenox Inc. · Not applicable, Interventional, and Treatment
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.
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.
233 studies on the registry are indexed under Hemorrhagic Stroke; 93 are open to participants now.
This study's planned enrollment of 214 is above the median of 58 across 156 interventional studies indexed under Hemorrhagic Stroke.
Browse Hemorrhagic Stroke studies →phenox Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Flow diversion using the p48 MW HPC Device: Flow diversion using the p64 MW HPC
Device: Flow 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.
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.
The Primary Efficacy and Performance Endpoint is a composite of 100% target aneurysm occlusion (Raymond-Roy Class I) without significant stenosis (defined as ≤50% stenosis) of the parent artery based on independent core lab evaluation of the 12-month follow-up angiogram (DSA), and no subsequent treatment at the target aneurysm at the 12-month follow-up visit.
Time frame: 12 months
The Primary Safety Endpoint: Number of subjects with ischemic or hemorrhagic stroke or neurologic death from treatment to 12-months, as adjudicated by a Clinical Events Committee.
The Primary Safety Endpoint is the incidence of major stroke (ischemic or hemorrhagic) in the territory supplied by the treated artery, defined as an increase in NIHSS score by 4 points, or neurologic death within 1 year after treatment.
Time frame: From treatment - 12 months
Secondary Safety Endpoint #1: Number of subjects with a modified Rankin Scale (mRS) score > 2
Morbi-mortality refers to the combined study of morbidity (the state of being diseased or unhealthy) and mortality (the state of being subject to death) that results in a modified Rankin Scale (mRS) score \> 2
Time frame: 30 days post procedure and at the following timepoints: 6-month, 1 year, 3 years, and 5 years
Secondary Safety Endpoint #2: Number of subjects with procedural and/or device-related serious adverse events (SAE)
The number of subjects that have a reported event related to the procedure, the device (based on FDAs definition of a serious adverse event), or both will be analyzed by an independent Clinical Events Committee
Time frame: 30 days post procedure and at the following timepoints: 6-months, 1 year, 3 years, and 5 years
Secondary Safety Endpoint #3: Number of subjects with a neurologic event of interest defined as any death, neurological death, target aneurysm rupture or re-rupture, target aneurysm retreatment, or intracranial hemorrhage
The number of subjects who have died by any cause, who have had their treated target aneurysm rupture or re-rupture, who have had their target aneurysm retreated, or who have had an intracranial hemorrhage, as adjudicated by an independent Clinical Events Committee
Time frame: 30 days post procedure and at the following timepoints: 6-months and 12-months post procedure
Additional Analysis #1: Number of subjects with 100% occlusion (Raymond-Roy Class I) of the target aneurysm at follow-up visits
The number of subjects with 100% occlusion (Raymond-Roy Class I) of the target aneurysm at follow-up visits will be analyzed
Time frame: Post procedure: 6-months, 1 year, 3 years and at 5 years
Additional Analysis #2: Number of subjects with retreatment of the target aneurysm
The number of subjects with target aneurysm retreatment will be analyzed
Time frame: Post Procedure: 6-months, 1 year, 3 years, and at 5 years
Additional Analysis #3: Number of subjects with a target aneurysm recanalization/recurrence
The number of subjects with target aneurysm recanalization or recurrence will be analyzed
Time frame: Post procedure: 6-months, 1 year, 3 years, and at 5 years
Additional Analysis #4: Number of subjects with significant (> 50% stenosis) parent artery stenosis, as assessed independent core laboratory post-procedure
The number of subjects with significant (\> 50% stenosis) parent artery stenosis, as assessed post-procedure by independent core lab will be analyzed
Time frame: Post procedure: 6-months, 1 year, 3 years, and at 5 years
Additional Analysis #5: Number of subjects with technical device success defined as complete coverage of the target aneurysm with ≥1 FMD) per subject at the target site during the index procedure
The number of subjects with complete coverage of the target aneurysm with ≥1 FMD per subject at the target site during the index procedure, as assessed by the independent core lab
Time frame: Immediately after the Index Procedure
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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