Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
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.
Phase
N/A
Funding Agency/Sponsor
Industry
Disease
Endovascular
Enrollment Eligibility
Inclusion Criteria (Imaging):
- Subject has a target intracranial aneurysm located in the internal carotid artery (up
to the terminus).
- Subject has a target intracranial aneurysm with an aneurysm neck ≥4mm or a
dome-to-neck ratio of < 2.
- Subject has a target intracranial aneurysm that has a parent vessel with diameter
1.5-5.0 mm distal/proximal to the target intracranial aneurysm.
Inclusion Criteria (Clinical):
- Subject (or subject's legally authorized representative) has provided written informed
consent using the IRB and Medtronic approved Informed Consent Form and agrees to
comply with protocol requirements. HIPAA/data protection authorization has been
provided and signed by the subject (or subject's legally authorized representative).
- Age 22-80 years at the time of consent.
- Life expectancy ≥3 years
- Subject has a mRS ≤ 2 at baseline to be determined by a certified independent assessor
at the site.
- Subject has already been selected for endovascular treatment of the target aneurysm.
- Subject's last recorded P2Y12 reaction units (PRU) value is between ≥60 and ≤200 prior
to study procedure. For OUS sites, a Thromboelastogram (TEG) test may be carried out
instead of the PRU test (depending on PRU test availability). In cases where TEG test
is carried out, the subject should have a pre-procedure therapeutic ADP% between >30%
to <90%.
- Subject has multiple increased risk factors for intracranial aneurysm rupture,
including but not limited to, aneurysm morphology, smoking, hypertension, diabetes,
age, prior and/or family history of rupture, and/or history of subarachnoid hemorrhage
that may result in a benefit risk profile of endovascular treatment to outweigh the
risks of intracranial aneurysm rupture during the subject's expected lifetime if left
untreated.
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:
1. Observed fetal posterior communicating artery (PComm) of fetal origin (A PComm of
fetal origin is defined as a small, hypoplastic, or absent P1 segment of the
posterior cerebral artery (PCA) with the PComm artery supplying a majority of
blood flow to the P2 and higher order segments of the PCA)
2. PComm overlapping with the aneurysm neck
3. PComm branch arising from the dome of the aneurysm
- 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:
1. Active bacterial infection
2. Contraindication to DAPT agents
- 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