Thrombus Aspiration in STEMI Patients With High Thrombus Burden
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Provincial People's Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years;
STEMI patients undergoing primary PCI within 12 hours after the onset of symptoms;
High thrombus burden after guidewire passes the lesion (TIMI thrombus grade ≥3);
Informed consent must be voluntary;
Disqualifiers
Haemodynamic instability or cardiogenic shock;
After thrombolytic therapy;
The predicted survival time is less than 6 months due to non-cardiac disease;
History of coronary artery bypass grafting;
Trial design
Design model
Parallel
Treatments tested in this trial
Thrombus aspiration
Procedure/SurgeryPercutaneous Coronary Intervention with manual aspiration thrombectomy
PCI Alone
Procedure/SurgeryPercutaneous Coronary Intervention without manual aspiration thrombectomy
Treatment groups
3,838 Participants
are divided into 2 treatment groupsGroup A: Thrombus aspirationExperimental treatment 1 intervention
Group B: PCI AloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Major adverse cardiovascular events
The first occurrence of cardiovascular death, recurrent myocardial infarction, stent thrombosis or target vessel revascularization
Time frame
up to180 daysSecondary outcomes
1
Stroke
The symptoms continuing for more than 24 hours or leading to death with no apparent cause other than vascular
Time frame
up to 30 days2
Composite adverse cardiocerebrovascular events
The first occurence of cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization or stroke.
Time frame
up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Guangdong Provincial People's Hospital
Lead sponsor
Zhongshan People's Hospital, Guangdong, China
Collaborator
Kaiping Central Hospital
Collaborator
Second Affiliated Hospital of Shantou University Medical College
Collaborator
The Third Xiangya Hospital of Central South University
Collaborator
Sihui City People's Hospital
Collaborator
Shenzhen Baoan District People's Hospital
Collaborator
People's Hospital of Nanxiong County
Collaborator
Yuebei People's Hospital
Collaborator
Weifang Medical University
Collaborator
Wuzhou Gongren Hospital
Collaborator
Dafeng Hospital of Chaoyang District in Shantou City
Collaborator
Dongguan People's Hospital
Collaborator
Yangchun People's Hospital
Collaborator
Taishan People's Hospital
Collaborator
The Second People's Hospital of Foshan
Collaborator
Guangzhou Hospital of integrated Traditional and West Medicine
Collaborator
Guangning People's Hospital
Collaborator
Foshan Sanshui District People's Hospital
Collaborator
Qingyuan People's Hospital
Collaborator
Luhe County People's Hospital
Collaborator
People's Hospital of Xinjiang Uygur Autonomous Region
Collaborator
The Fourth People's Hospital of Chenzhou
Collaborator
People's Hospital of Dapu County
Collaborator
Shenzhen People's Hospital
Collaborator
Heyuan people's Hospital
Collaborator
Huaiji People's Hospital
Collaborator
People's Hospital of Yingde City
Collaborator
Zhongshan Hospital Of Traditional Chinese Medicine
Collaborator
The Third Affiliated Hospital of Guangzhou Medical University
Collaborator
Lianzhou People's Hospital
Collaborator
Lianping Xian Ren Ming Yi Yuan
Collaborator
Guangxi Zhuang Autonomous Region Nationalities Hospital
Collaborator
Liuzhou Municipal Liutie Central Hospital
Collaborator
Chen Zhou 3RD People's Hospital
Collaborator
Longgang District People's Hospital of Shenzhen
Collaborator
The Affiliated Shunde Hospital of Jinan University
Collaborator
Shenzhen Longhua District Central Hospital
Collaborator
Shantou Central Hospital
Collaborator
Tongxiang First People's Hospital
Collaborator
Bobai County People's Hospital, Guangxi
Collaborator
Meizhou Traditional Chinese Medicine Hospital
Collaborator
The Third Affiliated Hospital of Sun Yat-Sen University, Yuedong Hospital
Collaborator
Shenzhen Third People's Hospital
Collaborator
Yangjiang People's Hospital
Collaborator
Jiangmen Central Hospital
Collaborator
Eighth Affiliated Hospital, Sun Yat-sen University
Collaborator
The First People's Hospital of Kashgar Erea
Collaborator
First People's Hospital of Foshan
Collaborator
Zhaoqing Gaoyao People's Hospital
Collaborator
People's Hospital of Nanhai District, Foshan
Collaborator
The Second Affiliated Hospital of Dalian Medical University
Collaborator
Nanning Second People's Hospital
Collaborator
The Second People's Hospital of Nanhai District of Foshan
Collaborator
Shangyou People's Hospital
Collaborator
Southern Medical University, China
Collaborator
Chaozhou Central Hospital
Collaborator
Chaoshan Hospital, the First Affiliated Hospital of Jinan University
Collaborator
Shenzhen Baoan District Traditional Chinese Medicine Hospital
Collaborator
The First Affiliated Hospital of Gannan Medical College
Collaborator
Puyang People's Hospital
Collaborator
Tongliao People's Hospital
Collaborator
Luohe Central Hospital
Collaborator
Linying County People's Hospital
Collaborator
Xiaolan People's Hospital of Zhongshan
Collaborator
The First Dongguan Affiliated Hospital of Guangdong Medical University
Collaborator
Source ClinicalTrials.gov