The Use of p48/64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms

Official title

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.

Overview

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.

Interventions

• 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 outcome measures

• 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 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]

Secondary outcome measures (3)

• Secondary Safety Endpoint #1: Number of subjects with 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) [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 [Time frame: 30 days post procedure and at the following timepoints: 6-months and 12-months post procedure]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 21 centers

• Barrow Neurological Institute — Phoenix
• UCSF Medical Center — San Francisco
• University of Colorado Anschutz — Aurora
• Swedish Medical Research Center — Englewood
• Baptist Health Research Institute — Jacksonville
• Piedmont Atlanta Hospital — Atlanta
• Advocate Lutheran General Hospital — Park Ridge
• University of Iowa — Iowa City
• … and 13 more centers

Identifiers

NCT: NCT07143019 · pCT-002-23

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗