NCT06186024招募中不适用
A PROSPECTIVE, MULTICENTER, SINGLE-ARM TRIAL FOR THE NEW SIZES OF BRIDGE STENTS FOR VERTEBRAL ARTERY STENOSIS: Bridge-MAX
MicroPort NeuroTech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年9月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Incidence of in-stent restenosis at 6 months postoperatively
研究概览
简要总结
Aprospective, multicentre, single-arm clinical trial in which approximately 36 subjects would be enrolled using the Bridge 4.5 mm and 5.0 mm stent in accordance with the inclusion and exclusion criteria in this protocol. The success rate of immediate post-procedure stent target lesion treatment was recorded for all subjects, and the incidence of in-stent restenosis (≥50% stenosis) was assessed by DSA imaging follow-up at 6 months (±30 days) post-procedure. The subjects were also followed up at 30 days (±7 days), 6 months (±30 days), and 12 months (±60 days) after stent implantation to assess safety events during the follow-up period. .
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or above (including 18 years old), 80 years old below (including 80 years old), male or women with pregnancy test (-);
- •Symptomatic vertebral artery stenosis patients who have failed in medical treatment (defined as patients who have suffered from stroke or TIA within 90 days, and are taking at least one antithrombotic drugs as well as interventions in other vascular risks, such as hypertension and hyperlipidemia decompression or lipid reducing);
- •DSA angiography showed target lesion stenosis degree ≥70% (Stenosis degrees are determined according to WASID method);
- •Diameter of normal blood vessels distal to the target lesion ≥3.5mm and the length of target lesion ≤23mm;
- •Modified Rankin score <3;
- •Patients who are suitable for implantation of rapamycin target eluting vertebral artery stent and are voluntary to
排除标准
- •Presence of tandem stenotic lesions (≥50% tandem stenosis) in the target lesion area; (2) TIA or non-disabling stroke due to factors other than vertebral artery stenosis (e.g. atrial fibrillation, etc.); (3) Previous surgical treatment or endovascular intervention in the target lesion area; (4) Comorbid severe systemic systemic diseases or other diseases with a potential risk of sudden death, or subjects with a life expectancy of <1 year; (5) Subjects with contraindications to heparin, aspirin, clopidogrel, or other antiplatelet drugs and who cannot tolerate anticoagulant and antiplatelet drug therapy; (6) Previous cerebral infarction with residual responsible vascular-related severe neurological deficits (mRS ≥3 points); (7) Previous severe myocardial infarction within 2 weeks; (8) Accompanied by other intracranial lesions such as intracranial haemorrhage, aneurysm, arteriovenous malformation, intracranial tumour, etc (9) Non-atherosclerotic stenosis such as arterial entrapment, smoker's disease, active arteritis, and unknown causes; (10) Severe tortuosity or calcification of the target vessel that precludes implantation of a stent or lesion that cannot be dilated; (11) Severe renal impairment, or those who are allergic or resistant to contrast agents, rapamycin (Rapamycin) and its derivatives, cobalt-based alloys, PDLLA; (12) Pregnant or lactating women; (13) Patients participating in other drug or device studies that have not met endpoints
结局指标
主要结局
Incidence of in-stent restenosis at 6 months postoperatively
时间窗: 180±30 days
次要结局
- Any death or stroke(1 year after stent implantation)
- Technical Success(post-implantation immediately)
- Any death or stroke during the follow-up associated with treatment in the target vessel supply region(1 year after stent implantation)
研究者
研究点 (1)
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