The Use of p48/64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
Sponsorphenox Inc.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Subject is ≥ 18 years
Subject has a mRS ≤2 before the index procedure
Saccular or fusiform morphology
Located in the internal carotid artery and its branches
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Flow diversion
DeviceThe 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.
Treatment groups
214 Participants
are divided into 1 treatment groupGroup A: Intervention/TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 monthsSecondary outcomes
1
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 years2
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 years3
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 procedureOther outcomes
1
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 years2
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 years3
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 years4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
phenox Inc.
Lead sponsor
Phenox GmbH
Collaborator
Source ClinicalTrials.gov