ChiCTR-TRC-06000689招募中2 期
Early stent-assisted angioplasty in symptomatic intracranial stenosis (ESASIS)
Division of Neurology, Department of Medicine and Therapeutics; Prince of Wales Hospital, The Chinese University of Hong Kong; and Vascular and Intervention Radiology Foundation1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2006年12月1日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
Early stent-assisted angioplasty in symptomatic intracranial stenosis (ESASIS)
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 年龄范围
- 18 至 80（—）
- 性别
- All
入选标准
- •Patient is at least 18 to 80 years of age, inclusive;
- •Acute ischemic stroke (within 4 weeks) attributable to a >70% stenosis of an intracranial artery (i.e. C6/7 internal carotid artery, M1 middle cerebral artery, V4 vertebral artery, or basilar artery) evidenced in DSA;
- •The target intracranial artery has a normal diameter of 2.00 mm to 4.5 mm; and the target area of stenosis is less than or equal to 14 mm in length;
- •A modified Rankin score of <3;
- •Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent.
排除标准
- •Any medical condition that would not allow the patient to adhere to the protocol or complete the study;
- •Patients for whom the required medications for the study are contra-indicated;
- •Brain infarct within previous 30 days of enrollment that is of sufficient size (> 5 cms) to be at risk of hemorrhagic conversion during or after stenting;
- •Active peptic ulcer disease, history of intracerebral (parenchymal) hemorrhage, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets <100,000, hematocrit <30, INR >1.5, clotting factor abnormality that increases the risk of bleeding, alcohol or substance abuse, uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic pressure > 115mm Hg), severe liver impairment (SGOT > 3 x normal, cirrhosis), creatinine > 3.0 (unless on dialysis);
- •Stroke etiology other than intracranial atherosclerosis, such as cardioembolism (atrial fibrillation, prosthetic heart valve, myocardial infarction within 6 weeks, mitral stenosis, intracardiac clot, bacterial endocarditis, or ventricular aneurysm), or a tandem high-grade (>70%) proximal extra-cranial carotid or vertebral stenosis;
- •Non-atherosclerotic intracranial stenosis, such as MoyaMoya disease, fibromuscular dysplasia, vasculitis or dissection;
- •Women who are pregnant or intend to become pregnant during the study;
- •Known intracranial tumor, arterio-venous malformation or aneurysm;
- •Life expectancy less than one year;
- •Previous intracranial stenting of the target artery;
- •Major surgical operation within the past 30 days.
研究组 & 干预措施
Two groups
early adjunctive stenting vs medical therapy alone, followed up for 12 months
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Transcranial Doppler for Internal Carotid Artery Stenting (TCD-ICAS)NCT07462546General Hospital of Shenyang Military Region232
招募中
不适用
MPR for Stroke Risk Assessment of ICASNCT07309718Xuanwu Hospital, Beijing400
尚未招募
4 期
Efficacy and Safety of Methylprednisolone After Flow-Diverter Stent Implantation in Unruptured Intracranial AneurysmsNCT07353749Duan Chuanzhi864
招募中
3 期
Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial StenosisNCT07356284ProMedica Health System342
招募中
4 期
Role of heart intervention (e.g, heart vessel ballooning and stenting) in heart attack patients presenting late between 12-72 hours of chest pain onsetCTRI/2024/07/070189Indian Council of Medical Research1,890