NCT04912570

Thrombus Aspiration in Heavy Thrombus Burden Acute ST-elevation Myocardial Infarction

Thrombus Aspiration in Heavy Thrombus Burden Acute ST-elevation Myocardial Infarction: TSUNAMI Trial

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: The Young Investigator Group of Cardiovascular Research · Network
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Recent guidelines for the management of ST-elevation myocardial infarction (STEMI) recommend against the routine use of thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI) (Class III indication). Yet, so far, there is limited data regarding its role STEMI patients with heavy thrombus burden (TB). The aim of this trial is to evaluate the effects of manual TA and PCI in comparison to conventional PCI alone in a real-life clinical trial among heavy TB STEMI patients undergoing PPCI.

Detailed description

Recent guidelines for the management of ST-elevation myocardial infarction (STEMI) recommend against the routine use of thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI) (Class III indication). Yet, so far, there is limited data regarding its role in STEMI patients with heavy thrombus burden (TB). The aim of this trial is to evaluate the effects of manual TA and PCI in comparison to conventional PCI alone in a real-life clinical trial among heavy TB STEMI patients undergoing PPCI.

Conditions

• Coronary Artery Disease
• Percutaneous Coronary Intervention
• ST Elevation Myocardial Infarction

Interventions

Type	Name	Description
PROCEDURE	Manual Thrombus Aspiration	Manual thrombus aspiration using one of the FDA approved aspirators will be done.
PROCEDURE	Standard PCI	Standard PCI according to the most recent guidelines

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-07-01
• Completion: 2024-12-01
• First posted: 2021-06-03
• Last updated: 2023-07-14

Locations

4 sites across 1 country: Egypt