Thrombus Aspiration in STEMI Patients With High Thrombus Burden

ST-segment Elevation Myocardial Infarction (STEMI) Clinical Trial

Official title:

Thrombus Aspiration in Primary Percutaneous Coronary Intervention for STEMI Patients With High Thrombus Burden

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04212494
• Other study ID #: GDREC2018404H(R2)
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2020
• Est. completion date: February 28, 2026

Study information

• Verified date: September 2023
• Source: Guangdong Provincial People's Hospital
• Contact: Pengchen He, MD
• Phone: 86-13829730152
• Email: drhepengcheng[@]aliyun.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study is intended to explore the efficacy of thrombus aspiration (TA) in ST-Segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden who received primary PCI within 12 hours after the onset of symptoms, reducing the incidence of cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization within 180 days or stroke in 30 days.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3838
• Est. completion date: February 28, 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST-segment Elevation Myocardial Infarction (STEMI)
• Thrombosis

Intervention

Procedure:
• Thrombus aspiration
Percutaneous Coronary Intervention with manual aspiration thrombectomy
• PCI Alone
Percutaneous Coronary Intervention without manual aspiration thrombectomy

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	West China Hospital	Chengdu	Sichuan
China	First People's Hospital of Foshan	Foshan	Guangdong
China	First People's Hospital of Shunde (Affiliated Hospital at Shunde, Southern Medical University)	Foshan	Guangdong
China	The Second People's Hospital of Nanhai District	Foshan	Guangdong
China	Fujian Provincial Hospital	Fuzhou	Fujian
China	GanZhou Municopal Hospital	Ganzhou	Jiangxi
China	Shangyou Hospital	Ganzhou	Jiangxi
China	Guangdong Provincial Hospital of traditional Chinese Medicine	Guangzhou	Guangdong
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Guangzhou General Hospital of Guangzhou Military Command	Guangzhou	Guangdong
China	Guangzhou Panyu Central Hospital	Guangzhou	Guangdong
China	Huadu District People's Hospital of Guangzhou	Guangzhou	Guangdong
China	Huangpu Division of The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Nanfang Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The first Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	The Second Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	Guilin people's Hospital	Guilin	Guangxi
China	Hainan People's Hospital	Haikou	Hainan
China	The Second Clinical College of Hainan Medical University	Haikou	Hainan
China	Huizhou Third People's Hospital	Huizhou	Guangdong
China	Jiangmen Central Hospital	Jiangmen	Guangdong
China	Kaiping Central Hospital	Kaiping	Guangdong
China	Kashgar first people's Hospital	Kashgar	Xinjiang
China	Yan'an Hospital of Kunming City	Kunming	Yunnan
China	Maoming People's Hospital	Maoming	Guangdong
China	Nanxiong people's Hospital	Nanxiong	Guangdong
China	The Second Affiliated Hospital of Shantou university Medical College	Shantou	Guangdong
China	Yue Bei People's Hospital	Shaoguan	Guangdong
China	Shaoxing people's Hospital	Shaoxing	Zhejiang
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong
China	Shenzhen Bao'an District People's Hospital	Shenzhen	Guangdong
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	The Eighth Affiliated Hospital, Sun Yat-Sen University	Shenzhen	Guangdong
China	Taishan people's Hospital	Taishan	Guangdong
China	The First Affilicated Hospital of Xinjiang Medical University	Urumqi	Xinjiang
China	Affiliated Hospital, Weifang Medical University	Weifang	Shandong
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Wuhan Asia Heart Hospital	Wuhan	Hubei
China	The first Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	People's Hospital of Yangjiang City	Yangjiang	Guangdong
China	The Second Affiliated Hospital of Guangdong Medical University	Zhanjiang	Guangdong
China	Sihui people's Hospital	Zhaoqing	Guangdong
China	Zhongshan People's Hospital	Zhongshan	Guangdong
China	The Fifth Affiliated Hospital, Sun Yat-Sen University	Zhuhai	Guangdong
China	Zhuhai people's Hospital	Zhuhai	Guangdong

Sponsors (14)

Lead Sponsor

Collaborator

Guangdong Provincial People's Hospital

Central South University, Fifth Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital of Guangxi Medical University, First People's Hospital of Foshan, Fujian Provincial Hospital, Hainan People's Hospital, Jiangmen Central Hospital, Peking University Shenzhen Hospital, Shenzhen People's Hospital, Sichuan Provincial People's Hospital, West China Hospital, Wuhan Asia Heart Hospital, ZhuHai Hospital

Country where clinical trial is conducted

China, 

References & Publications (11)

Beran 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. — View Citation

Burzotta 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. — View Citation

DeWood 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. — View Citation

Frobert 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. Erratum In: N Engl J Med. 2014 Aug 21;371(8):786. — View Citation

Herrick JB. Landmark article (JAMA 1912). Clinical features of sudden obstruction of the coronary arteries. By James B. Herrick. JAMA. 1983 Oct 7;250(13):1757-65. No abstract available. — View Citation

Ibanez 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. — View Citation

Jolly 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. — View Citation

Jolly 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. — View Citation

Levine 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. Erratum In: J Am Coll Cardiol. 2016 Mar 29;67(12):1506. — View Citation

Sianos G, Papafaklis MI, Daemen J, Vaina S, van Mieghem CA, van Domburg RT, Michalis LK, Serruys PW. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardial infarction: the importance of thrombus burden. J Am Coll Cardiol. 2007 Aug 14;50(7):573-83. doi: 10.1016/j.jacc.2007.04.059. Epub 2007 Jul 30. — View Citation

Vlaar 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular events	The first occurrence of cardiovascular death, recurrent myocardial infarction, stent thrombosis or target vessel revascularization	up to180 days
Secondary	Stroke	The symptoms continuing for more than 24 hours or leading to death with no apparent cause other than vascular	up to 30 days
Secondary	Composite adverse cardiocerebrovascular events	The first occurence of cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization or stroke.	up to 1 year