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| Name | Class |
|---|---|
| Phenox GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention/Treatment | Experimental | Device: Flow diversion using the p48 MW HPC Device: Flow diversion using the p64 MW HPC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flow diversion | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From treatment - 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days post procedure and at the following timepoints: 6-month, 1 year, 3 years, and 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Post procedure: 6-months, 1 year, 3 years and at 5 years |
| Additional Analysis #2: Number of subjects with retreatment of the target aneurysm |
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:
Subject or subject's legally authorized representative (LAR) has provided written informed consent and has agreed to comply with study procedures.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mairéad Cleary | Contact | +353 91 740 100 | mairead.cleary@wallabyphenox.com | |
| Nguyet T Labenski | Contact | nguyet.labenski@wallabyphenox.com |
| Name | Affiliation | Role |
|---|---|---|
| Demetrius Lopes, MD | Advocate Aurora Research Institute, LLC | Principal Investigator |
| Jared Knopman, MD | The Joan and Sanford I. Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Recruiting | Phoenix | Arizona | 85013 | United States |
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Prospective, multicenter, single-arm
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| 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 | 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 | 30 days post procedure and at the following timepoints: 6-months and 12-months post procedure |
The number of subjects with target aneurysm retreatment will be analyzed |
| 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 | 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 | 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 | Immediately after the Index Procedure |
| Eytan Raz, MD | NYU Langone Health | Principal Investigator |
| UCSF Medical Center | Recruiting | San Francisco | California | 94143 | United States |
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| University of Colorado Anschutz | Recruiting | Aurora | Colorado | 80045 | United States |
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| Swedish Medical Research Center | Recruiting | Englewood | Colorado | 80113 | United States |
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| Baptist Health Research Institute | Recruiting | Jacksonville | Florida | 32207 | United States |
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| Piedmont Atlanta Hospital | Recruiting | Atlanta | Georgia | 30309 | United States |
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| Advocate Lutheran General Hospital | Recruiting | Park Ridge | Illinois | 60068 | United States |
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| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
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| Tufts Medical Center | Recruiting | Boston | Massachusetts | 02111 | United States |
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| WashU Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
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| UBNS | Recruiting | Buffalo | New York | 14203 | United States |
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| North Shore University Hospital - Northwell Health | Recruiting | Manhasset | New York | 11030 | United States |
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| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
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| NewYork-Presbyterian / Weill Cornell Medical Center | Recruiting | New York | New York | 10065 | United States |
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| Stony Brook University Hospital | Recruiting | Stony Brook | New York | 11794 | United States |
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| East Carolina University Health Medical Center | Recruiting | Greenville | North Carolina | 27834 | United States |
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| The University of Oklahoma | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
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| Oregon Health & Science University Hospital (OHSU) / Oregon Stroke Center | Recruiting | Portland | Oregon | 97239 | United States |
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| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| University of Washington - Harborview Medical Center | Recruiting | Seattle | Washington | 98104 | United States |
|
| ID | Term |
|---|---|
| D000083302 | Hemorrhagic Stroke |
| D002532 | Intracranial Aneurysm |
| D000783 | Aneurysm |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020765 | Intracranial Arterial Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
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