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The purpose of this study is to assess the safety and effectiveness of the Pipeline™ Vantage Embolization Device with Shield Technology™ in the treatment of intracranial aneurysms within the intended indication for use.
Full description
The safety of the Pipeline™ Vantage will be assessed through incidence of major stroke in the territory supplied by the treated artery or neurological death at 1-year post-procedure. The effectiveness of the Pipeline™ Vantage will be assessed through incidence of complete aneurysm occlusion (Raymond Roy Scale Class 1) without significant parent artery stenosis (≤ 50%) or retreatment of the target aneurysm at 1-year post-procedure. Additional safety and effectiveness analyses will include incidence of major stroke in the territory supplied by the treated artery or neurological death at 2- and 3-years post-procedure, incidence of major stroke in the territory supplied by the treated artery or neurological death at 30 days post-procedure, incidence of delayed intraparenchymal hemorrhage >30 days post-procedure through 1-year post-procedure, incidence of subjects with disabling strokes that have a mRS decline to a score of 3 or more (mRS ≥ 3) due to a stroke-related cause assessed at a minimum of 90 days post-stroke event at 1 year, 2 year, and 3 year post-procedure, incidence of successful device implantation at the target site, incidence of complete aneurysm occlusion (Raymond Roy Class 1) at 1- and 3-years post-procedure, incidence of target aneurysm recurrence at 1- and 3-years post-procedure.
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Inclusion and exclusion criteria
Inclusion Criteria (Imaging):
Inclusion Criteria (Clinical):
Exclusion Criteria (Imaging):
Subject has internal carotid artery bifurcation aneurysm.
Aneurysms that arise from the Posterior Communicating Artery (PComm).
The internal carotid artery aneurysms of the C7 segment will be excluded under the following conditions:
Subject has aneurysm arising from internal carotid artery but is primarily fed by posterior circulation (i.e., retrograde flow from the basilar artery) as confirmed by DSA
Exclusion Criteria (Clinical):
Subject requires treatment of another aneurysm (with another treatment modality) within the affected territory of the target aneurysm during the study period.
Subject has received an intracranial implant (e.g. coils) in the area of the target intracranial aneurysm within the past 6 months prior to the study procedure.
Subject has had a SAH and/or target aneurysm rupture in the past 30 days prior to the study procedure.
Subject has undergone a surgery including endovascular procedures in the last 30 days prior to the study procedure.
Aneurysm vessel characteristics (e.g. parent vessel stenosis, irregular morphology) that would preclude the device from fully confirming to the parent vessel to reduce any risk of embolic complications, retreatment, or device movement.
Subject has active vasospasm, malignant brain tumor or vascular malformation (e.g. arteriovascular malformation).
History of major bleeding disorder (based on coagulation profile and platelet count) and/or subject presents with signs of active bleeding.
Subject requires adjunctive device use (e.g. coils) during the index procedure.
Subject has extradural target aneurysm <12mm which is not symptomatic or not exhibiting aneurysm growth (exception: unless it is a fusiform aneurysm <12 mm i.e., asymptomatic extradural fusiform aneurysms <12 mm can be included).
Any known contraindication to treatment with the Pipeline™ Vantage Embolization Device with Shield Technology™, or use of antiplatelet therapy including:
Pre-existing stent is in place in the parent artery at the target intracranial aneurysm location
Platelet count < 100 x 10^3 cells/mm^3 or known platelet dysfunction.
The Investigator determines that the health of the subject or the validity of the study outcomes (e.g., high risk of neurologic events, conditions that may increase the chance of stroke) may be compromised by the subject's enrollment.
Subject is pregnant or wishes to become pregnant during the first year of study participation.
Subject is participating in another clinical trial at any time during the duration of the study that could confound the treatment or outcomes of this investigation.
Subject with known allergy to platinum or cobalt chromium alloy (including the major elements platinum, cobalt, chromium, nickel or molybdenum).
History of previous acute ischemic stroke
Subject is unable to undergo DSA or CTA imaging at follow-up
Primary purpose
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14 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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