NCT03994822已完成不适用
pRESET for Occlusive Stroke Treatment
phenox Inc.46 个研究点 分布在 2 个国家目标入组 340 人开始时间: 2019年10月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 340
- 试验地点
- 46
- 主要终点
- Primary Safety Endpoint: Device- or procedure-related symptomatic intracerebral hemorrhage (sICH)
研究概览
简要总结
Compare the safety and effectiveness of pRESET to Solitaire in the treatment of stroke related to large vessel occlusion
详细描述
To determine the safety and effectiveness of pRESET for the treatment of acute ischemic stroke within 8 hours of symptom onset (defined as time patient was last seen well) due to large vessel occlusion and to compare safety and effectiveness to the predicate device, Solitaire™ Platinum revascularization device
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The blinded assessor performs all study assessments during and after hospital discharge (i.e., 24 hours, Day 7/Discharge (whichever is earlier), and 30 and day 90 visits
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical signs consistent with acute ischemic stroke
- •Subject is able to be treated within 8 hours of stroke symptom onset and within 1.5 hours (90 min) from screening CT / MRI to groin puncture.
- •Pre-stroke modified Rankin Score of 0 or 1
- •NIHSS ≥6 at the time of enrolment
- •If tPA is indicated, initiation of IV tPA should be administered as soon as possible and no later than 3.0 hours of onset of stroke symptoms (onset time is defined as the last time when the patient was witnessed to be at baseline neurologic status), with investigator verification that the subject has received/is receiving the correct IV tPA dose (0.9mg/kg) for the estimated weight.
- •Expanded Thrombolysis in Cerebral Infarction (eTICI) 0-1 flow confirmed by angiography that is accessible to the mechanical thrombectomy device in the following locations:
- •Intracranial internal carotid
- •M1 and/or M2 segment of the MCA
- •Carotid terminus
- •Vertebral artery
- •Basilar artery
- •Note: M1 segment of the MCA is defined as the arterial trunk from its origin at the ICA to the first bifurcation or trifurcation into major branches neglecting the small temporo-polar branch.
- •Imaging scores as follows:
- •· ASPECTS score must be 6-10 on NCCT or DWI-MRI.
- •If automated core volume assessment software is used:
- •MR diffusion-weighted imaging (DWI) ≤50cc
- •Computed tomography perfusion (CTP) core ≤50 cc
- •Subject is willing to conduct protocol-required follow-up visits.
- •A valid completed informed consent by participant or LAR (Legally Authorized Representative)
排除标准
- •Subject who has received IA-tPA prior to enrolment in the study
- •Female who is pregnant or lactating or has a positive pregnancy test at time of admission.
- •Rapid neurological improvement prior to study enrolment suggesting resolution of signs/symptoms of stroke
- •Known serious sensitivity to radiographic contrast agents
- •Known sensitivity to nickel, titanium metals, or their alloys
- •Subjects already enrolled in other investigational studies that would interfere with study endpoints
- •Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency. (A subject without history or suspicion of coagulopathy does not require INR or prothrombin time lab results to be available prior to enrolment.)
- •Known renal failure as defined by a serum creatinine > 2.0 mg/dl (or 176.8 μmol/l) or glomerular filtration rate (GFR) <
- •Subject who requires hemodialysis or peritoneal dialysis, or who has a contraindication to an angiogram for whatever reason.
- •Life expectancy of less than 90 days
- •Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
- •Suspicion of aortic dissection
- •Subject with a comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
- •Subject is known to currently use or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day).
- •Known arterial condition (e.g., proximal vessel stenosis or pre-existing stent) that would prevent the device from reaching the target vessel and/or preclude safe recovery of the device
- •Subject who requires balloon angioplasty or stenting of the carotid artery at the time of the index procedure
- •Angiographic evidence of carotid dissection
- •Imaging exclusion criteria:
- •CT or MRI evidence of hemorrhage on presentation
- •CT or MRI evidence of mass effect or intra-cranial tumor (except small meningioma)
- •CT or MRI evidence of cerebral vasculitis
- •CT or MRI-DWI showing ASPECTS 0-
- •Alternatively, if automated core volume assessment software is used, MRI-DWI or CTP core > 50cc.
- •CT/MRI shows evidence of carotid dissection or complete cervical carotid occlusion requiring a stent
- •Any imaging evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention (e.g. inability to navigate to target lesion, moderate/large infarct with poor collateral circulation, etc.).
- •Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation) as confirmed by angiography, or clinical evidence of bilateral strokes or strokes in multiple territories
结局指标
主要结局
Primary Safety Endpoint: Device- or procedure-related symptomatic intracerebral hemorrhage (sICH)
时间窗: 24 (-8/+12) hours
Proportion of subjects with device- or procedure-related symptomatic intracerebral hemorrhage (sICH)
Primary Effectiveness Endpoint: Patients with a Modified Rankin Scale (mRS) </= 2
时间窗: 90 (+/-15) days
Global disability assessed via the blinded evaluation of the proportion of patients with a Modified Rankin Scale (mRS) \</= 2
次要结局
- Successful Revascularization measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI)(During Index Procedure)
- Successful Revascularization on first pass measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI)(During Index Procedure)
- Overall mortality following the index stroke(90 (+/-15) days)
- Distribution of mRS shift across the entire spectrum of disability(90 (+/-15) days)
研究者
研究点 (46)
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