Thrombus Aspiration in STEMI Patients With High Thrombus Burden

NCT04212494 · tracked via the Priya Life Science China tracker

Sponsor

Guangdong Provincial People's Hospital

Phase

Not applicable

Started

2020-08-30

Last updated

2026-09-09

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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