Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With Gā¦ (NCT06872684) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD)
United States183 participantsStarted 2025-06-20
Plain-language summary
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.
Who can participate
Age range18 Years ā 80 Years
SexALL
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Inclusion criteria
ā. Age is ā„18 and ā¤80 years at the time of consent
ā. Has a single unruptured target intracranial aneurysm (IA) of any size with the following characteristics:
ā. Is located on the internal carotid artery or its branches
ā. Has a wide neck (wide neck typically defined as neck width ā„ 4 millimeter (mm), or dome to neck ratio ā¤ 2.0) or no discernible neck
ā. Aneurysm is either saccular or fusiform in nature
ā. Has a parent vessel diameter ā„ 3.0 mm to ā¤ 6.0 mm at the largest diameter
ā. There is documented risk-benefit of endovascular treatment that outweighs the risks of intracranial aneurysm rupture during the subject's expected lifetime if left untreated.
Exclusion criteria
ā. Has an extradural target aneurysm
ā. Has a target aneurysm in the posterior circulation
ā. 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)
ā. Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation
ā
What they're measuring
1
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).
Timeframe: 12 month Ā± 3 months
2
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.
. Has vessel characteristics, such as severe tortuosity (cavernous Internal Carotid Artery (cICA) Type IV1), stenosis (\>70%), or morphology that would preclude safe endovascular access or proper deployment of the trial device to the target aneurysm
ā. Received previous treatment for the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
ā. Has a medical contraindication to trial or procedure related antiplatelet medications (aspirin, clopidogrel/Plavix, ticagrelor, and heparin), local or general anesthesia, or life-threatening allergy to contrast dye
ā. Has a known severe allergy to nickel, chromium cobalt, tungsten, or platinum