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NCT04212494
Thrombus Aspiration in STEMI Patients With High Thrombus Burden
Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 3838
Sponsor: Guangdong Provincial People's Hospital
Location: Fujian Provincial Hospital Fuzhou Fujian
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.
Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 18 years;
2. STEMI patients undergoing primary PCI within 12 hours after the onset of symptoms;
3. High thrombus burden after guidewire passes the lesion (TIMI thrombus grade ≥3);
4. Informed consent must be voluntary;
Exclusion Criteria:
1. Haemodynamic instability or cardiogenic shock;
2. After thrombolytic therapy;
3. The predicted survival time is less than 6 months due to non-cardiac disease;
4. History of coronary artery bypass grafting;
5. Participate in other researches within 30 days;
6. Preoperative gastrointestinal bleeding or contraindications to dual antiplatelet therapy;
7. Patients were considered unsuitable by other researchers.
Source: ClinicalTrials.gov (NCT04212494). StuddyBuddy aggregates publicly available trial information.