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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 214
- Locations
- 24
- Primary Endpoint
- 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.
Study Overview
Brief 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Intervention/Treatment
Device: Flow diversion using the p48 MW HPC Device: Flow diversion using the p64 MW HPC
Intervention: Flow diversion (Device)
Outcomes
Primary Outcomes
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.
Time Frame: 12 months
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.
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.
Time Frame: 12 months
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.
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.
Time Frame: From treatment - 12 months
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.
Secondary Outcomes
- Secondary Safety Endpoint #1: Number of subjects with a modified Rankin Scale (mRS) score > 2(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)(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(30 days post procedure and at the following timepoints: 6-months and 12-months post procedure)
- Secondary Safety Endpoint #1: Number of subjects with a modified Rankin Scale (mRS) score > 2(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)(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(30 days post procedure and at the following timepoints: 6-months and 12-months post procedure)