A Study of the Pipeline™ Vantage Embolization Device With Shield Technology™ for Endovascular Treatment of Wide-Necked Intracranial Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 6
- 主要终点
- Safety: Incidence of Major Stroke or Neurological Death
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 <
- •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.
- •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.
排除标准
- •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:
- •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)
- •PComm overlapping with the aneurysm neck
- •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:
- •Active bacterial infection
- •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
结局指标
主要结局
Safety: Incidence of Major Stroke or Neurological Death
时间窗: 1 year post-procedure
Incidence of major stroke in the territory supplied by the treated artery or neurological death.
Effectiveness: Incidence of Complete Aneurysm Occlusion
时间窗: 1 year post-procedure
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.
次要结局
- Effectiveness: Incidence of Successful Device Implantation(Day 0)
- Effectiveness: Incidence of Complete Aneurysm Occlusion(3 years post-procedure)
- Effectiveness: Incidence of Target Aneurysm Recurrence(3 years post-procedure)
- Safety: Incidence of Major Stroke(30 days post-procedure)
- Safety: Incidence of Delayed Intraparenchymal Hemorrhage(>30 days post-procedure through 1 year post-procedure)
- Safety: Incidence of Subjects With Disabling Strokes(Assessed from procedure through 3 years post-procedure)