NL-OMON56525尚未招募不适用
Envast* thrombectomy device as adjunctive reperfusion modality in ST-segment elevation myocardial infarction - Nature Study
Vesalio0 个研究点目标入组 70 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
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 99（—）
入选标准
- •1. Age >=18 years
- •2. Chest pain for >20 min with an electrocardiographic ST-segment elevation >=1
- •mm in two or more contiguous electrocardiogram (ECG) leads or an infero-lateral
- •myocardial infarction (MI) with ST segment depression of >=1 mm in >=2 of leads
- •V1-3 with a positive terminal T wave.
- •3. TIMI Thrombus Grade >= 3 in the infarct related artery. In cases where TIMI
- •Thrombus Grade is equal to 5 (i.e. TIMI 0 flow in the infarcted artery), TIMI
- •Thrombus Grade of at least 3 has to be re-confirmed with AWI. Patients showing
- •TIMI Thrombus Grade of less than 3 upon AWI are no longer eligible for
- •randomization.
- •4. Start of intervention within 8 h of symptom onset
- •5. Deferred consent after intervention signed by capable subject, signed by
- •legal representative in case of incapable subject (subject remains included if
- •deferred post-interventional consent was not signed before death).
排除标准
- •1. Unconscious patients
- •2. Infarct related artery diameter, at visual assessment, smaller than 2.5 mm
- •3. Presence of severely calcified plaque(s) proximal to or at the site of the
- •culprit lesion(s)
- •4. Presence of extreme vessel tortuosity proximal to or at the site of the
- •culprit lesion(s)
- •5. Women of childbearing potential (e.g. below 55 years of age, who have not
- •undergone tubal ligation, ovariectomy or hysterectomy)
- •6. Stent thrombosis as culprit lesion
- •7. Previous myocardial infarction in the same territory (i.e. same target
- •8. Participation in another interventional clinical trial
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