NCT05316311已完成不适用
Implantation of CERENOVUS ENTERPRISE 2 Intracranial Stent in Patients With Severe Symptomatic Intracranial Atherosclerotic Stenosis: A Multicenter, Prospective and Single-Arm Study in China
Medos International SARL28 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2022年5月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 试验地点
- 28
- 主要终点
- Percentage of Participants with In-Stent Restenosis
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of CERENOVUS ENTERPRISE 2 intracranial stent implantation in treatment of participants with severe symptomatic intracranial atherosclerotic stenosis.
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
- •Pre-procedure inclusion criteria
- •Participants aged 22-80 years old
- •All participants are required to meet at least one additional criteria (a-f) provided below to qualify for the study; (a) insulin dependent diabetes for at least 15 years; (b) at least 2 of the following atherosclerotic risk factors: hypertension (blood pressure [BP] greater than or equal to [>=] 140/90 or on antihypertensive therapy); dyslipidemia (low density lipoprotein [LDL] 130 milligrams per deciliter [mg/dl] or high density lipoprotein [HDL] less than [<] 40 mg/dl or fasting triglycerides >= 150 mg/dl or on lipid lowering therapy); smoking; abnormal glucose metabolism (fasting blood glucose >= 6.2 millimole per liter (mmol/L) or 2 hours postprandial blood glucose >= 7.8mmol/L); family history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, peripheral vascular surgery in parent or sibling who was <55 years of age for men or <65 for women at the time of the event ; (c) history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease ; (d) any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery, coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery that was documented by non-invasive vascular imaging or catheter angiography and is considered atherosclerotic ; (e) Aortic arch atheroma or atherosclerotic aortic aneurysm documented by non-invasive vascular imaging or catheter angiography ; (f) High resolution magnetic resonance imaging (MRI) imaging confirmed the presence of atherosclerotic plaques in the target arterial stenosis
- •Participants with symptomatic intracranial atherosclerotic stenosis who is receiving medical treatment (that is, receiving at least one antithrombotic medication and vascular risk factor management) but still had recurrent (2 or more) ischemic strokes during the medical treatment period within past year
- •Vascular diameter proximal to the stenosis must be measured at 2.0-4.0 millimeters (mm)
- •Modified Rankin Scale (mRS) <= 2
- •Stenosis of 70%-99% on non-invasive vascular imaging or digital subtraction angiography (DSA), with normal distal vessel
- •Participant is willing and able to return for all follow-up visits required by the protocol
- •Participants understand the purpose and requirements of the study and have signed an informed consent form Intra procedure
- •Stenosis of 70 percent (%) -99% on digital subtraction angiography (DSA), with normal distal vessel
排除标准
- •Participant underwent an acute ischemic stroke within 2 weeks
- •Participants in whom one stent can't cover the lesion length or the use of multiple stents is required
- •Greater than (>) 50% stenosis proximal or distal to the target intracranial lesion
- •Intracranial arterial stenosis related to non-atherosclerotic factors, such as: arterial dissection, moya-moya disease; vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebrospinal fluid pleocytosis; radiation-induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process, and developmental or genetic abnormalities
- •Participants with symptoms of cerebral ischemia caused by cardiac embolism
- •Severe vascular tortuosity, highly calcified or anatomy that would preclude the safe introduction of a guiding catheter, guiding sheath or stent placement
- •Myocardial infarction within previous 30 days
- •Permanent atrial fibrillation, persistent atrial fibrillation, any episode of paroxysmal atrial fibrillation within the past six months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation
- •Intolerance or allergic reaction to any of antithrombotic therapy or medicine used during the procedure
- •History of life-threatening allergy to contrast medium. If not life threatening and can be effectively pre-treated, participant can be enrolled at investigators' discretion
- •Surgery within previous 30 days or planned in the next 90 days after enrollment
- •Intracranial hemorrhage within 3 months
- •Concomitant intracranial tumor, aneurysm or arteriovenous malformation
- •Haemoglobin <10 grams per deciliter (g/dL), blood platelet count <80000 per milliliters (/ml), international normalization ratio >1.5, or other uncorrectable coagulopathies.
- •Life expectancy of <3 years due to the concomitant illness.
- •Pregnant or lactating women
- •Participants judged unsuitable for stenting and angioplasty by the investigator
研究组 & 干预措施
CERENOVUS ENTERPRISE 2 Intracranial Stent
Experimental
Participants with severe symptomatic intracranial artery stenosis will be treated with CERENOVUS ENTERPRISE 2 Intracranial Stent.
干预措施: CERENOVUS ENTERPRISE 2 Intracranial Stent (Device)
结局指标
主要结局
Percentage of Participants with In-Stent Restenosis
时间窗: At 12 months post-procedure
In-stent restenosis greater than (\>) 50 percent (%) at 12 months post-procedure as assessed by an independent Imaging Core Lab will be reported. The percent stenosis of an intracranial artery is calculated according to the warfarin-aspirin symptomatic intracranial disease (WASID) criteria: percent stenosis= (\[1-{Dstenosis/Dnormal}\]) \* 100, where Dstenosis = the diameter of the artery at the site of the most severe stenosis and Dnormal = the diameter of the proximal normal artery.
次要结局
- Number of Participants with In-Stent Restenosis(At 6 months post-procedure)
- Modified Rankin Scale (mRS) Scores(At 30 days, 6 months and 12 months post-procedure)
- Number of Participants with Technical Success(Immediately post-procedure (Day 0))
- National Institutes of Health Stroke Scale (NIHSS) Scores(At 6 months and 12 months post-procedure)
- Number of Participants Free of Ischemic Stroke within the Territory of Stented Vessel(From 30 days to 12 months post-procedure)
研究者
研究点 (28)
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