The objective of the Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms with Surpass Elite with GUARDian Flow Diverter (GUARD) trial is to evaluate the safety and efficacy of the Surpass Elite with Guardian Flow Diverter System (FDS) in the treatment of unruptured, wide-neck saccular or fusiform, intracranial aneurysms (IAs) located on the internal carotid artery (ICA) or its branches.
Age is ≥18 and ≤80 years at the time of consent
Is located on the internal carotid artery or its branches
Has a wide neck (wide neck typically defined as neck width ≥ 4 millimeter (mm), or dome to neck ratio ≤ 2.0) or no discernible neck
Aneurysm is either saccular or fusiform in nature
Has an extradural target aneurysm
Has a target aneurysm in the posterior circulation
Perforator or branch vessel, inclusive of the posterior communicating artery, arises from the target aneurysm body or neck (branches or arteries must arise or connect from the parent vessel separate from the aneurysm or neck to not be excluded from trial)
Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation
Single group
Surpass Elite with Guardian Flow Diverter System
DeviceThe Surpass Elite with Guardian Flow Diverter System is indicated for use in the endovascular treatment of adults (age 18 or above) with unruptured wide-neck saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter ≥ 3.0 millimeter (mm) and ≤ 6.0 mm and located on the Internal Carotid Artery (ICA) or its branches.
The primary safety endpoint: Number of subjects with neurologic death or major ipsilateral stroke through 12 months as adjudicated by an independent Clinical Events Committee (CEC).
Neurological death defined as stroke-related death and related to the vascular territory associated with target aneurysm treatment. Major ipsilateral stroke defined as a stroke with an increase in National Institutes of Health Stroke Scale (NIHSS) score ≥ 4 points persisting ≥ 24 hours and related to the vascular territory associated with target aneurysm treatment.
The primary efficacy endpoint: Number of subjects with 100% occlusion of the target aneurysm without significant parent artery stenosis, and with no target aneurysm retreatment through the 12-month follow-up visit timepoint.
The primary efficacy endpoint is a composite of 100% occlusion (Raymond-Roy Class 1, complete occlusion) of the target aneurysm without significant parent artery stenosis (significant parent artery stenosis is defined as \> 50% stenosis, per independent core lab assessment of digital subtraction angiography \[DSA\] images acquired at 12 months \[± 90 days\] post-procedure), and with no target aneurysm retreatment through the 12-month follow-up visit timepoint.
Secondary Safety Endpoint #1: Number of subjects with neurological death or disabling stroke as adjudicated by an independent Clinical Events Committee (CEC).
Neurological death defined as stroke-related death and related to the vascular territory associated with target aneurysm treatment. Disabling stroke defined as stroke related to the vascular territory associated with target aneurysm treatment that results in a modified Rankin Score (mRS) score ≥ 3, as assessed by an independent qualified (certified or with documented qualification per institution standard of care) assessor at a minimum of 90 days post stroke event. The number of subjects with neurological deaths or disabling strokes as adjudicated by an independent Clinical Events Committee (CEC) will be analyzed.
Secondary Safety Endpoint #2: Number of subjects with stroke related to the vascular territory associated with target aneurysm treatment as adjudicated by an independent Clinical Events Committee (CEC).
The number of subjects with strokes related to the vascular territory associated with target aneurysm treatment as adjudicated by an independent Clinical Events Committee (CEC) will be analyzed.
Secondary Safety Endpoint #3: Number of subjects with combined stroke and transient ischemic attack (TIA) events as adjudicated by a CEC
The number of subjects with combined stroke and transient ischemic attack (TIA) events as adjudicated by an independent Clinical Events Committee (CEC) will be analyzed
Secondary Efficacy Endpoint #1: Number of subjects with 100% occlusion (Raymond-Roy Class 1, complete occlusion) of the target aneurysm at follow-up visits
The number of subjects with 100% occlusion (Raymond-Roy Class 1, complete occlusion) of the target aneurysm at follow-up visits, per independent core lab assessment of DSA images will be analyzed
Click on the lead sponsor to view all of their trials.
