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临床试验/NCT06327659
NCT06327659尚未招募3 期

Efficacy of Using 50 ml Syringe Manual Thrombectomy Catheter in Patients With Heavy Thrombus Burden Undergoing Primary Percutaneous Coronary Intervention

Helwan University1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
尚未招募
入组人数
88
试验地点
1
主要终点
MBG after PCI

研究概览

简要总结

In high thrombus burden subgroup of Acute STEMI, manual aspiration thrombectomy was associated with reduced cardiovascular death but increased stroke or transient ischemic attack. The role of aspiration thrombectomy is still a matter of active debate. Manual aspiration suffers from decreasing aspiration force as the syringe fills with fluid and requires the operator to exchange syringes during the procedure to maintain suction.

详细描述

Acute ST-segment elevation myocardial infarction (STEMI) poses a major hazard to human life and health due to its high morbidity and deaths. The frequency of STEMI is increasing. Although dual antiplatelet treatment (DAPT) and primary percutaneous coronary intervention (PPCI) have enhanced survival in STEMI suffers during the last 20 years. Complications after myocardial infarction continue to be a major contributor to high mortality and disability.

Treatment focuses on minimizing infarct size by reopening the occluded artery and restoring myocardial perfusion While PPCI is an established treatment option and can reliably re-establish flow, it can also cause distal embolization, resulting in persistent microvascular obstruction and poor myocardial perfusion. Poor myocardial perfusion after PCI is associated with worse left ventricular functional recovery and increased long-term mortality. By removing thrombotic material, aspiration thrombectomy before PCI may reduce the risk of distal embolization and improve myocardial perfusion. A meta-analysis of large randomized trials comparing aspiration thrombectomy and PCI alone found that routine manual aspiration thrombectomy did not improve clinical outcomes. However, in the high thrombus burden subgroup, manual aspiration thrombectomy was associated with reduced cardiovascular death but increased stroke or transient ischemic attack.

For select cardiac populations, particularly those with high thrombus burden, the role of aspiration thrombectomy is still a matter of active debate. Manual aspiration suffers from decreasing aspiration force as the syringe fills with fluid and requires the operator to exchange syringes during the procedure to maintain suction.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with STEMI within 12-24 h of symptom onset in native coronary vessel with heavy thrombus burden (Thrombolysis in Myocardial Infarction [TIMI] thrombus grade 4 or 5 on angiography after the guidewire crossed the target lesion)

排除标准

  • Very delayed STEMI presentation.
  • STEMI with low thrombus burden.
  • STEMI with cardiogenic shock.
  • Failed recanalization of culprit vessel.
  • Complex coronary anatomy candidates for coronary artery bypass graft.

研究组 & 干预措施

Group I

Active Comparator

干预措施: 30 mL syringe manual thrombectomy catheter (Device)

Group II

Experimental

干预措施: 50 mL syringe manual thrombectomy catheter (Device)

结局指标

主要结局

MBG after PCI

时间窗: During procedure

Myocardial blush grade (MBG): * Grade 0: No myocardial blush or contrast density. * Grade 1: Minimal myocardial blush or contrast density. * Grade 2: Moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral non-infarct-related coronary artery. * Grade 3: Normal myocardial blush or contrast density comparable with that obtained during angiography of a contralateral or ipsilateral non-infarct-related coronary artery.

TIMI flow grade after PCI

时间窗: During procedure

Thrombolysis in Myocardial Infarction (TIMI) flow grades: * Grade 0: There is no antegrade flow or perfusion beyond the blockage. * Grade 1 indicates that the contrast material was able to flow through the blockage during the cineangiographic recording series without totally obstructing the coronary bed distal to the obstruction. * Grade 2: The coronary artery distal to the occlusion is opacified by the contrast material at a much slower pace than in regions unaffected by the prior closure. * Grade 3: indicates contrast material is cleared from the affected bed at the same rate as it is cleared from an unaffected bed in the same or opposite artery.

次要结局

  • Composite rate of occurrence of MACE(30 days after PCI)
  • Rate of recurrent myocardial infarction(30 days after PCI)
  • Rate of cardiogenic shock(30 days after PCI)
  • Rate of cardiovascular death(30 days after PCI)
  • Rate of stroke(30 days after PCI)
  • Rate of NYHA IV heart failure(30 days after PCI)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arafa Gomaa

Cardiology consultant

Helwan University

研究点 (1)

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