NCT04212494

Thrombus Aspiration in STEMI Patients With High Thrombus Burden

Thrombus Aspiration in Primary Percutaneous Coronary Intervention for STEMI Patients With High Thrombus Burden

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,838 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, open-label, randomized, controlled, parallel group study, in which ST-segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(TIMI thrombus grade ≥3) are included. Patients are randomized to be treated with or without manual thrombus aspiration(TA) during primary percutaneous coronary intervention(PPCI) by a ratio of 1:1.

Detailed description

This study is intended to explore the efficacy of thrombus aspiration (TA) in ST-Segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden who received primary PCI within 12 hours after the onset of symptoms, reducing the incidence of cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization within 180 days or stroke in 30 days.

Conditions

• ST-segment Elevation Myocardial Infarction (STEMI)

Interventions

Type	Name	Description
PROCEDURE	Thrombus aspiration	Percutaneous Coronary Intervention with manual aspiration thrombectomy
PROCEDURE	PCI Alone	Percutaneous Coronary Intervention without manual aspiration thrombectomy

Timeline

• Start date: 2020-08-30
• Primary completion: 2025-08-31
• Completion: 2026-02-28
• First posted: 2019-12-27
• Last updated: 2024-11-18

Locations

50 sites across 1 country: China