Clinical Trials in China / NCT04212494
Recruiting
Not applicable
Thrombus Aspiration in STEMI Patients With High Thrombus Burden
NCT04212494 · tracked via the Priya Life Science China tracker
Condition(s) studied
ST-segment Elevation Myocardial Infarction (STEMI)
Investigational drug(s) / intervention(s)
Thrombus aspirationPCI Alone
Thrombus aspiration: Percutaneous Coronary Intervention with manual aspiration thrombectomy
PCI Alone: Percutaneous Coronary Intervention without manual aspiration thrombectomy
Study 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
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.
Primary outcome measure(s)
- Major adverse cardiovascular events — up to180 days
The first occurrence of cardiovascular death, recurrent myocardial infarction, stent thrombosis or target vessel revascularization
Trial sites (50)
| Facility | City | Region | Status |
|---|---|---|---|
| Fujian Provincial Hospital | Fuzhou | Fujian | Not Yet Recruiting |
| First People's Hospital of Foshan | Foshan | Guangdong | Recruiting |
| The Second People's Hospital of Nanhai District | Foshan | Guangdong | Recruiting |
| First People's Hospital of Shunde (Affiliated Hospital at Shunde, Southern Medical University) | Foshan | Guangdong | Recruiting |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | Recruiting |
| Guangzhou Panyu Central Hospital | Guangzhou | Guangdong | Not Yet Recruiting |
| Guangzhou General Hospital of Guangzhou Military Command | Guangzhou | Guangdong | Not Yet Recruiting |
| The first Affiliated Hospital, Sun Yat-Sen University | Guangzhou | Guangdong | Not Yet Recruiting |
| Guangdong Provincial Hospital of traditional Chinese Medicine | Guangzhou | Guangdong | Not Yet Recruiting |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | Not Yet Recruiting |
| The Second Affiliated Hospital, Sun Yat-Sen University | Guangzhou | Guangdong | Not Yet Recruiting |
| Zhujiang Hospital of Southern Medical University | Guangzhou | Guangdong | Not Yet Recruiting |
| Nanfang Hospital | Guangzhou | Guangdong | Not Yet Recruiting |
| Huangpu Division of The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | Not Yet Recruiting |
| Huadu District People's Hospital of Guangzhou | Guangzhou | Guangdong | Not Yet Recruiting |
| Huizhou Third People's Hospital | Huizhou | Guangdong | Not Yet Recruiting |
| Jiangmen Central Hospital | Jiangmen | Guangdong | Recruiting |
| Kaiping Central Hospital | Kaiping | Guangdong | Recruiting |
| Maoming People's Hospital | Maoming | Guangdong | Not Yet Recruiting |
| The Second Affiliated Hospital of Shantou university Medical College | Shantou | Guangdong | Recruiting |
| Yue Bei People's Hospital | Shaoguan | Guangdong | Recruiting |
| Shenzhen People's Hospital | Shenzhen | Guangdong | Recruiting |
| The Eighth Affiliated Hospital, Sun Yat-Sen University | Shenzhen | Guangdong | Recruiting |
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | Not Yet Recruiting |
| Shenzhen Bao'an District People's Hospital | Shenzhen | Guangdong | Recruiting |
| Taishan people's Hospital | Taishan | Guangdong | Recruiting |
| Nanxiong people's Hospital | Xiongzhou | Guangdong | Recruiting |
| People's Hospital of Yangjiang City | Yangjiang | Guangdong | Recruiting |
| The Second Affiliated Hospital of Guangdong Medical University | Zhanjiang | Guangdong | Not Yet Recruiting |
| Sihui people's Hospital | Zhaoqing | Guangdong | Recruiting |
| Zhongshan People's Hospital | Zhongshan | Guangdong | Recruiting |
| The Fifth Affiliated Hospital, Sun Yat-Sen University | Zhuhai | Guangdong | Not Yet Recruiting |
| Zhuhai people's Hospital | Zhuhai | Guangdong | Not Yet Recruiting |
| Guilin people's Hospital | Guilin | Guangxi | Not Yet Recruiting |
| The Second Clinical College of Hainan Medical University | Haikou | Hainan | Not Yet Recruiting |
| Hainan People's Hospital | Haikou | Hainan | Not Yet Recruiting |
| Wuhan Asia Heart Hospital | Wuhan | Hubei | Not Yet Recruiting |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | Recruiting |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | Not Yet Recruiting |
| GanZhou Municopal Hospital | Ganzhou | Jiangxi | Not Yet Recruiting |
+ 10 more sites — see the full list on the official registry below.
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04212494 on ClinicalTrials.gov ↗ ← All trials in China