NCT04969471进行中（未招募）不适用
An Interventional, Prospective, Randomized, Multi-Center, Assessor-Blinded Study Designed to Assess the Safety and Effectiveness of the enVast Coronary Thrombectomy System as an Adjunctive Measure to Conventional Intervention in Subjects Presenting With ST-segment Elevation Myocardial Infarction (STEMI)
Vesalio12 个研究点 分布在 3 个国家目标入组 148 人开始时间: 2021年12月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 148
- 试验地点
- 12
- 主要终点
- Infarct size
研究概览
简要总结
This study is designed to compare the safety and effectiveness of blood clot (thrombus) removal in subjects presenting with ST-segment elevation myocardial infarction (STEMI) with the enVast coronary system versus conventional intervention.
详细描述
A prospective, multi-center, randomized clinical trial designed to assess the safety and effectiveness of the enVast coronary thrombectomy system as an adjunctive measure to conventional intervention in subjects presenting with ST-segment elevation myocardial infarction (STEMI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ≥ 18 years
- •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.
- •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.
- •Start of intervention within 8 h of symptom onset
- •Subject is willing and able to provide informed consent prior to the intervention
排除标准
- •Unconscious patients
- •Infarct related artery diameter, at visual assessment, smaller than 2.5 mm
- •Presence of severely calcified plaque(s) proximal to or at the site of the culprit lesion(s)
- •Presence of extreme vessel tortuosity proximal to or at the site of the culprit lesion(s)
- •Women of child-bearing potential (e.g. below 55 years of age, who have not undergone tubal ligation, ovariectomy or hysterectomy and last menstruation within the last 12 months)
- •Stent thrombosis as culprit lesion
- •Previous myocardial infarction in the same territory (i.e. same target vessel)
- •Participation in another interventional clinical trial
研究组 & 干预措施
Thrombectomy Arm
Experimental
enVast stent deployed at occlusion site as first measure to obtain reperfusion and withdraw the clot
干预措施: enVast stent (Device)
Conventional Treatment Arm
Experimental
Treatment strategies may include balloon angioplasty, manual aspiration thrombectomy and/or coronary stenting.
干预措施: conventional treatment (Procedure)
结局指标
主要结局
Infarct size
时间窗: three days post intervention
size assessed by measurements of creatine kinase
Infarct size
时间窗: At 3 days
size assessed by measurements of CK-MB (U/L)
次要结局
- MRI core lab Infarct size outcome(At 3 days)
- CK(at 3 days)
- hsTroponin T(at 3 days)
- ECG core lab outcome measures(At Procedure)
- Angio core lab TIMI Flow(At Procedure)
- Echo core lab LVEF outcome measures(At discharge (an average of 3 days))
- BNP(At discharge (an average of 3 days))
- Diuretic treatment(At discharge (an average of 3 days))
- Histopathology(During procedure)
- Additional MRI analysis(At procedure)
- Primary safety endpoint(Day 3)
- CEC outcome measures(at 1-year follow-up)
- Other important safety endpoints(throughout 1-year follow-up)
- MRI Core Lab myocardial salvage index(At 3 days)
- MRI Core Lab microvascular obstruction outcome(At 3 days)
- MRI Core Lab LV volume outcome(At 3 days)
- MRI Core lab intramyocardial haemorrhage outcome(At 3 days)
- MRI core Lab left ventricle and right ventricle thrombosis outcome(At 3 days)
- MRI Core Lab RV function outcome(At 3 days)
- Core lab T2 mapping of the left ventricle(At 3 days)
- MRI Core Lab wall motion score index(At 3 days)
- Angio Core Lab Corrected TIMI frame count(At Procedure)
- Angio Core Lab Myocardial Blush Grade(At Procedure)
- Echo Core Lab LV volume(12 months)
- Echo Core Lab wall motion score index(12 months)
- Echo Core Lab wall thickness(At discharge (an average of 3 days))
- Echo Core lab myocardial deformation Outcome(At discharge (an average of 3 days))
- Echo Core lab right ventricle function assessment(At discharge (an average of 3 days))
研究者
研究点 (12)
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