Long-term Outcomes of MicroNet-covered Stent Routine Use for Stroke Prevention in Symptomatic and Increased-risk Asymptomatic Carotid Stenosis Patients Requiring Revascularization by Neurovascular Team Decision: PARADIGM-EXTEND
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 2
- 主要终点
- MACNE (Major Adverse Cardiac and Neurological Events)
研究概览
简要总结
All-comer study of unselected patients suitable for carotid artery revascularization to evaluate the feasibility, efficacy and safety of first line endovascular revasculariztion using MicroNet covered stent (CGuard™) in the treatment of consecutive symptomatic and increased-stroke-risk asymptomatic carotid lesions that require revascularization by Neurovascular Team decision.
详细描述
Independent investigator initiated, academic, single arm, open-label, non-randomized, prospective, multicenter, multispecialty trial of CGuard™ routine use in all-comer population of consecutive patients with symptomatic or increased-stroke-risk asymptomatic carotid stenosis.
Increased-stroke-risk is defined as the following patient and/or lesion characteristics:
thrombus containing, documented progressive, irregular, ulcerated lesion; evidence of ipsilateral ischemic cerebral injury in MRI or CT imaging; contralateral stroke in relation to carotid stenosis; contralateral artery occlusion.
The main objective of this observational study is to evaluate (1) the periprocedural feasibility and efficacy of CGuard™ stent system in the treatment of carotid artery stenosis (2) long-term efficacy and safety of routine CGuard™ stent system use.
The study hypothesis is that the novel CGuard™ MicroNet® covered stent is safe and effective for a majority of consecutive patients considered to require carotid revascularization.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient > 18 years old qualified by NeuroVascular Team for carotid revascularization according to local standards of care
- •Signed informed consent
- •Agreement (routin un this group of patients) to clinical and ultrasonographis follow up.
- •Angiographic Inclusion Criteria:
- •De-novo atherosclerotic lesions or neo-atherosclerosis
- •Symptomatic patients (history of transient ischemic attack, ischaemic stroke or amaurosis fugax within 6 months from index procedure) with index artery stenosis ≥50% assessed in angiography with NASCET method or
- •Asymptomatic patients with index artery stenosis ≥70-80% assessed in angiography with NASCET method
排除标准
- •Lack of NeuroVascular Team agreement on carotid revascularization indication
- •Lack of signed informed consent
- •Estimated life expectancy less than 1 year
- •Chronic renal failure with serum creatinine level > 3.0 mg/dL
- •Myocardial Infarction within 72 hours prior to index procedure.
- •Pregnant women
- •Diagnosed coagulopathies
- •History of contrast media allergy, not reacting to pharmacotherapy
- •Angiographic Exclusion Criteria:
- •Index lesion occlusion
- •Common carotid artery stent protruding to aortic arch
- •Anatomical conditions restricting stent implantation
- •Significant common carotid artery stenosis proximal to index lesion (unless treated)
结局指标
主要结局
MACNE (Major Adverse Cardiac and Neurological Events)
时间窗: 12 months
Death, Stroke, Myocardial Infarction.
次要结局
- Procedural success(Within 48 hours from index procedure)
- In-hospital MACNE (Major Adverse Cardiac and Neurological Events)(Within 48 hours from index procedure)
- Functional MRI efficacy assessment.(Within 48 hours)
- Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel(One year after index procedure.)
- 30-day MACNE (Major Adverse Cardiac and Neurological Events)(30 days)
- Intravascular Ultrasound Stent Evaluation(Periprocedural)
- Incidence of any periprocedural complications(Within 48 hours)
- Diffusion Weighted MRI efficacy assessment.(Within 48 hours)
- Ipsilateral Stroke incidence(From one year until five years after the procedure.)
- Any stroke incidence(Within five years from the procedure.)