Phase III Study of Pharos Vitesse Neurovascular Stent System Compared to Best Medical Therapy for the Treatment of Ischemic Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 125
- 主要终点
- Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months
研究概览
简要总结
The main objective of this study is to prospectively evaluate the safety, probable benefit, and effectiveness of the PHAROS Vitesse Neurovascular Stent System in a multicenter, randomized clinical trial.
A secondary objective of this study is to evaluate the impact of stenting in the neurovasculature to treat cerebral ischemia on other outcomes such as hospital length of stay, charges, and costs.
详细描述
1.1 Study Hypothesis Treatment of cerebral or retinal ischemia due to plaque in the neurovasculature using the PHAROS Vitesse Stent System plus medical therapy will provide additional clinical benefit over medical therapy alone.
1.2 Primary Effectiveness Endpoint
The primary effectiveness endpoint consists of a composite of the two following outcomes:
- Stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization
- Hard TIA in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 post-randomization
1.3 Safety Outcomes
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has at least one neurovascular lesion (70-99%) stenosis [internal carotid, middle cerebral, vertebral artery (C4-BA), and/or basilar artery] symptomatic with a hard TIA or stroke attributable to the territory of the lesion within the past 30 days. An intracranial tandem lesion (50-99%) stenosis may be treated if normal artery segment is sufficient length to avoid overlapping stents.
- •Target vessel diameter / lesion length measurements are within one of the below per angiogram:
- •Vessel diameter is ≥ 2.0 mm and < 2.5 mm / lesion length is ≤ 16 mm, or
- •Vessel diameter is ≥ 2.5 mm and < 3.0 mm / lesion length is ≤ 18 mm, or
- •Vessel diameter is ≥ 3.0 mm and < 4.5 mm / lesion length is ≤ 26 mm, or
- •Vessel diameter is ≥ 4.5 mm and ≤ 5.0 mm / lesion length is ≤ 31 mm
- •Subject has normal artery adjacent to each stenosis; diameter 2.0 mm - 5.0 mm
- •Subject age is 18-85 years
- •Life expectancy is at least 2 years
- •Subject 's mRS score is ≤ 3
- •Subject is available for study follow-up visits (e.g., lives within 3 hours of research center)
- •Subject is willing and cognitively able to provide Informed Consent (consent may be indicated verbally and signed by neutral witness if stroke has impaired hand or visual function)
排除标准
- •Subject has contraindications for balloon expandable stent, e.g.
- •Extreme tortuosity at, or proximal to, target lesion,
- •More than 2 lesions with > 50% stenosis (including vertebral ostia and common carotid disease),
- •Carotid or vertebral dissection
- •CT scan or MRI evidence of any of the following:
- •Intracranial hemorrhage of type PH1 or PH2
- •Subdural or epidural hemorrhage
- •Mass effect, or
- •Intracranial tumor (except small meningioma)
- •Subject has a previous stent in the territory of the target lesion(s)
- •Subject has a previous coil or clip placed in the territory of the target lesion within 6 months
- •Subject has a potential source of cardiac embolism requiring anticoagulation therapy (e.g., atrial fibrillation, intracardiac thrombus or vegetation, significant mitral stenosis, mechanical heart valve, congestive heart failure with EF <30%, or endocarditis)
- •Subject has concurrent intracranial pathology, e.g.
- •Vasculitis documented by biopsy results
- •Ruptured Aneurysm
- •Unruptured aneurysm > 7mm
- •Subject has uncontrolled hypertension (systolic >185 mmHg or diastolic >110 mmHg)
- •Hemoglobin < 10 g/dL; platelet count < 100,000; or INR > 1.5 (e.g., use of warfarin)
- •Subject has an uncorrectable bleeding diathesis
- •Subject's neurological status is unstable and rapidly declining (NIHSS score increased > 4 points within 48 hours prior to randomization)
- •Subject has a contraindication for combination antithrombotic treatment (e.g., clopidogrel and aspirin) such as peptic ulcer disease
- •Subject history indicates high risk of non-compliance (e.g., substance abuse, psychosocial issues, etc.)
- •Subject has a known history contraindicating contrast dye or iodine (vs. sensitivity which can be safely controlled by antihistamine, steroid, etc.)
- •Subject is pregnant or plans to become pregnant in the next 12 months
- •Myocardial infarction within past 3 months
- •Treatment with tPA or other thrombolytic agent within 48 hours prior to randomization
- •Major surgery or trauma within 2 weeks prior to randomization
- •Enrollment in another investigational device or drug study that may confound the results
研究组 & 干预措施
Stent Group
Medical therapy + PHAROS Vitesse neurovascular stent ("Stent Group")
干预措施: Pharos Vitesse Neurovascular Stent System (Stent implantation) + Medical therapy (Aspirin and Clopidogrel) (Device)
Medical Therapy Group
Medical therapy alone ("Medical Therapy Group")
干预措施: Aspirin and Clopidogrel (Medical therapy) (Drug)
结局指标
主要结局
Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months
时间窗: One Year
The primary effectiveness endpoint was a composite of the two following outcomes: * Stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization * Hard Transient Ischemic Attack (TIA) in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 post-randomization A subject was deemed to be a primary endpoint success if neither of these outcomes occurred. The Kaplan-Meier success rate at 12-months post-operatively was calculated with Kaplan-Meier time-to-event methodology, where the time variable for patients who were successful (no stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of last follow-up, and the time variable for patients who were not successful (had a stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of the first event (stroke with 12 months or hard TIA between 2 days and 12 months).
次要结局
未报告次要终点