NL-OMON48800已完成不适用
Carotid Artery ImPlant for Trapping UpstReam Emboli <br>(CAPTURE) for Preventing Stroke in Atrial Fibrillation <br>Patients - CAPTURE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Atrial fibrillation (AF)
- •2. CHA2DS2-VASc score >= 2
- •3. Age > 50
- •4. Unsuitable for oral anticoagulation therapy (OAC), defined as
- •contraindicated for OAC,
- •patient refusing OAC, or physician is reluctant to prescribe OAC
- •5. Maximal (systolic) CCA diameter range: >= 4.8mm and <= 9.8mm
- •6. CCA accessibility: up to 60mm from skin to CCA center, safe approach
- •7. Patient is willing to provide informed consent
- •8. Patient is willing to complete all scheduled follow-up
排除标准
- •1. Evidence of carotid stenosis > 30% [CCA, internal carotid artery (ICA), or
- •external carotid artery (ECA)]
- •2. Evidence of any atherosclerotic disease in CCA above the clavicles
- •3. Evidence of carotid dissection
- •4. Pre-existing stent(s) in CCA
- •5. Contraindicated or allergic to antiplatelet therapy, or any medication
- •required during
- •6. Recent stroke, TIA, or myocardial infarction (MI) within two months prior to
- •7. Female who is pregnant or who is planning to become pregnant during the
- •8. Life expectancy of less than 1 year
- •9. Active systemic infection
- •10. Known sensitivity to nickel or titanium metals, or their alloys
- •11. Known hereditary or acquired coagulation disorders
- •12. Any planned surgical or endovascular procedure within 14 days prior to or
- •after the index procedure
- •13. A co-morbid disease or condition that could confound the neurological and
- •evaluations or compromise survival or ability to complete follow-up assessments
- •14. Current use or a recent history of illicit drug(s) use or alcohol abuse
- •(defined as regular
- •or daily consumption of more than four alcoholic drinks per day)
- •15. Active participation in another investigational drug or device treatment
- •16. Any other condition that in the opinion of the investigator may adversely
- •safety of the subject or would limit the subject's ability to complete the
研究者
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