Thrombus Aspiration in STEMI Patients With High Thrombus Burden
Thrombus Aspiration in Primary Percutaneous Coronary Intervention for STEMI Patients With High Thrombus Burden
1 other identifier
interventional
3,838
1 country
50
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2020
Longer than P75 for not_applicable
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2019
CompletedFirst Posted
Study publicly available on registry
December 27, 2019
CompletedStudy Start
First participant enrolled
August 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2026
CompletedNovember 18, 2024
October 1, 2024
5 years
December 24, 2019
November 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major adverse cardiovascular events
The first occurrence of cardiovascular death, recurrent myocardial infarction, stent thrombosis or target vessel revascularization
up to180 days
Secondary Outcomes (2)
Stroke
up to 30 days
Composite adverse cardiocerebrovascular events
up to 1 year
Study Arms (2)
Thrombus aspiration
EXPERIMENTALUpfront manual thrombus aspiration followed by PCI
PCI Alone
ACTIVE COMPARATORPCI without upfront manual thrombus aspiration
Interventions
Percutaneous Coronary Intervention with manual aspiration thrombectomy
Percutaneous Coronary Intervention without manual aspiration thrombectomy
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
- Participate in other researches within 30 days;
- Preoperative gastrointestinal bleeding or contraindications to dual antiplatelet therapy;
- Patients were considered unsuitable by other researchers.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guangdong Provincial People's Hospitallead
- Zhongshan People's Hospital, Guangdong, Chinacollaborator
- Kaiping Central Hospitalcollaborator
- Second Affiliated Hospital of Shantou University Medical Collegecollaborator
- The Third Xiangya Hospital of Central South Universitycollaborator
- Sihui City People's Hospitalcollaborator
- Shenzhen Baoan District Shiyan People's Hospitalcollaborator
- People's Hospital of Nanxiong Countycollaborator
- Yuebei People's Hospitalcollaborator
- Weifang Medical Universitycollaborator
- Wuzhou Gongren Hospitalcollaborator
- Dafeng Hospital of Chaoyang District in Shantou Citycollaborator
- Shenzhen Baoan People's Hospitalcollaborator
- Dongguan People's Hospitalcollaborator
- Yangchun People's Hospitalcollaborator
- Taishan People's Hospitalcollaborator
- The Second People's Hospital of Foshancollaborator
- Guangzhou Hospital of integrated Traditional and West Medicinecollaborator
- Guangning People's Hospitalcollaborator
- Foshan Sanshui District People's Hospitalcollaborator
- Qingyuan People's Hospitalcollaborator
- Luhe County People's Hospitalcollaborator
- People's Hospital of Xinjiang Uygur Autonomous Regioncollaborator
- The Fourth People's Hospital of Chenzhoucollaborator
- People's Hospital of Dapu Countycollaborator
- Shenzhen People's Hospitalcollaborator
- Heyuan people's Hospitalcollaborator
- Huaiji People's Hospitalcollaborator
- People's Hospital of Yingde Citycollaborator
- Qingyuan Hospital of Traditional Chinese Medicine Affiliated To Guangzhou University of Traditional Chinese Medicinecollaborator
- Zhongshan Hospital Of Traditional Chinese Medicinecollaborator
- The Third Affiliated Hospital of Guangzhou Medical Universitycollaborator
- Lianzhou People's Hospitalcollaborator
- Lianping Xian Ren Ming Yi Yuancollaborator
- Guangxi Zhuang Autonomous Region Nationalities Hospitalcollaborator
- Liuzhou Municipal Liutie Central Hospitalcollaborator
- Chen Zhou 3RD People's Hospitalcollaborator
- Longgang District People's Hospital of Shenzhencollaborator
- The Affiliated Shunde Hospital of Jinan Universitycollaborator
- Shenzhen Longhua District Central Hospitalcollaborator
- Shantou Central Hospitalcollaborator
- Tongxiang First People's Hospitalcollaborator
- Bobai County People's Hospital, Guangxicollaborator
- Meizhou Traditional Chinese Medicine Hospitalcollaborator
- The Third Affiliated Hospital of Sun Yat-Sen University, Yuedong Hospitalcollaborator
- Shenzhen Third People's Hospitalcollaborator
- Yangjiang People's Hospitalcollaborator
- Jiangmen Central Hospitalcollaborator
- Eighth Affiliated Hospital, Sun Yat-sen Universitycollaborator
- The First People's Hospital of Kashgar Ereacollaborator
- First People's Hospital of Foshancollaborator
- Zhaoqing Gaoyao People's Hospitalcollaborator
- People's Hospital of Nanhai District, Foshancollaborator
- The Second Affiliated Hospital of Dalian Medical Universitycollaborator
- Nanning Second People's Hospitalcollaborator
- The Second People's Hospital of Nanhai District of Foshancollaborator
- Shangyou People's Hospitalcollaborator
Study Sites (50)
Fujian Provincial Hospital
Fuzhou, Fujian, 350001, China
First People's Hospital of Foshan
Foshan, Guangdong, 528000, China
The Second People's Hospital of Nanhai District
Foshan, Guangdong, 528251, China
First People's Hospital of Shunde (Affiliated Hospital at Shunde, Southern Medical University)
Foshan, Guangdong, 528300, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000, China
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong, 510000, China
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, 510010, China
The first Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510080, China
Guangdong Provincial Hospital of traditional Chinese Medicine
Guangzhou, Guangdong, 510120, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
The Second Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510235, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280, China
Nanfang Hospital
Guangzhou, Guangdong, 510515, China
Huangpu Division of The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510700, China
Huadu District People's Hospital of Guangzhou
Guangzhou, Guangdong, 510800, China
Huizhou Third People's Hospital
Huizhou, Guangdong, 516002, China
Jiangmen Central Hospital
Jiangmen, Guangdong, 529030, China
Kaiping Central Hospital
Kaiping, Guangdong, 529300, China
Maoming People's Hospital
Maoming, Guangdong, 525000, China
The Second Affiliated Hospital of Shantou university Medical College
Shantou, Guangdong, 515041, China
Yue Bei People's Hospital
Shaoguan, Guangdong, 512026, China
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020, China
The Eighth Affiliated Hospital, Sun Yat-Sen University
Shenzhen, Guangdong, 518033, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518035, China
Shenzhen Bao'an District People's Hospital
Shenzhen, Guangdong, 518101, China
Taishan people's Hospital
Taishan, Guangdong, 529200, China
Nanxiong people's Hospital
Xiongzhou, Guangdong, 512400, China
People's Hospital of Yangjiang City
Yangjiang, Guangdong, 529500, China
The Second Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
Sihui people's Hospital
Zhaoqing, Guangdong, 526200, China
Zhongshan People's Hospital
Zhongshan, Guangdong, 528403, China
The Fifth Affiliated Hospital, Sun Yat-Sen University
Zhuhai, Guangdong, 519000, China
Zhuhai people's Hospital
Zhuhai, Guangdong, 519000, China
Guilin people's Hospital
Guilin, Guangxi, 541002, China
The Second Clinical College of Hainan Medical University
Haikou, Hainan, 460106, China
Hainan People's Hospital
Haikou, Hainan, 570311, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 13787318063, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
GanZhou Municopal Hospital
Ganzhou, Jiangxi, 341000, China
Shangyou Hospital
Ganzhou, Jiangxi, 341200, China
Affiliated Hospital, Weifang Medical University
Weifang, Shandong, 261031, China
The first Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
West China Hospital
Chengdu, Sichuan, 610041, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Kashgar first people's Hospital
Kashgar, Xinjiang, 844000, China
The First Affilicated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
Yan'an Hospital of Kunming City
Kunming, Yunnan, 65005, China
Shaoxing people's Hospital
Shaoxing, Zhejiang, 312000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Related Publications (11)
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PMID: 6350634BACKGROUNDDeWood MA, Spores J, Notske R, Mouser LT, Burroughs R, Golden MS, Lang HT. Prevalence of total coronary occlusion during the early hours of transmural myocardial infarction. N Engl J Med. 1980 Oct 16;303(16):897-902. doi: 10.1056/NEJM198010163031601.
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PMID: 17692740BACKGROUNDBeran G, Lang I, Schreiber W, Denk S, Stefenelli T, Syeda B, Maurer G, Glogar D, Siostrzonek P. Intracoronary thrombectomy with the X-sizer catheter system improves epicardial flow and accelerates ST-segment resolution in patients with acute coronary syndrome: a prospective, randomized, controlled study. Circulation. 2002 May 21;105(20):2355-60. doi: 10.1161/01.cir.0000016350.02669.1d.
PMID: 12021220BACKGROUNDBurzotta F, Trani C, Romagnoli E, Mazzari MA, Rebuzzi AG, De Vita M, Garramone B, Giannico F, Niccoli G, Biondi-Zoccai GG, Schiavoni G, Mongiardo R, Crea F. Manual thrombus-aspiration improves myocardial reperfusion: the randomized evaluation of the effect of mechanical reduction of distal embolization by thrombus-aspiration in primary and rescue angioplasty (REMEDIA) trial. J Am Coll Cardiol. 2005 Jul 19;46(2):371-6. doi: 10.1016/j.jacc.2005.04.057.
PMID: 16022970BACKGROUNDVlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study. Lancet. 2008 Jun 7;371(9628):1915-20. doi: 10.1016/S0140-6736(08)60833-8.
PMID: 18539223BACKGROUNDFrobert O, Lagerqvist B, Olivecrona GK, Omerovic E, Gudnason T, Maeng M, Aasa M, Angeras O, Calais F, Danielewicz M, Erlinge D, Hellsten L, Jensen U, Johansson AC, Karegren A, Nilsson J, Robertson L, Sandhall L, Sjogren I, Ostlund O, Harnek J, James SK; TASTE Trial. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med. 2013 Oct 24;369(17):1587-97. doi: 10.1056/NEJMoa1308789. Epub 2013 Aug 31.
PMID: 23991656BACKGROUNDJolly SS, Cairns JA, Yusuf S, Meeks B, Pogue J, Rokoss MJ, Kedev S, Thabane L, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemela K, Steg PG, Bernat I, Xu Y, Cantor WJ, Overgaard CB, Naber CK, Cheema AN, Welsh RC, Bertrand OF, Avezum A, Bhindi R, Pancholy S, Rao SV, Natarajan MK, ten Berg JM, Shestakovska O, Gao P, Widimsky P, Dzavik V; TOTAL Investigators. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med. 2015 Apr 9;372(15):1389-98. doi: 10.1056/NEJMoa1415098. Epub 2015 Mar 16.
PMID: 25853743BACKGROUNDLevine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Ting HH, O'Gara PT, Kushner FG, Ascheim DD, Brindis RG, Casey DE Jr, Chung MK, de Lemos JA, Diercks DB, Fang JC, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2015 ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention and the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction. J Am Coll Cardiol. 2016 Mar 15;67(10):1235-1250. doi: 10.1016/j.jacc.2015.10.005. Epub 2015 Oct 21. No abstract available.
PMID: 26498666BACKGROUNDJolly SS, James S, Dzavik V, Cairns JA, Mahmoud KD, Zijlstra F, Yusuf S, Olivecrona GK, Renlund H, Gao P, Lagerqvist B, Alazzoni A, Kedev S, Stankovic G, Meeks B, Frobert O. Thrombus Aspiration in ST-Segment-Elevation Myocardial Infarction: An Individual Patient Meta-Analysis: Thrombectomy Trialists Collaboration. Circulation. 2017 Jan 10;135(2):143-152. doi: 10.1161/CIRCULATIONAHA.116.025371. Epub 2016 Dec 9.
PMID: 27941066BACKGROUNDIbanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
PMID: 28886621BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2019
First Posted
December 27, 2019
Study Start
August 30, 2020
Primary Completion
August 31, 2025
Study Completion
February 28, 2026
Last Updated
November 18, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share