ClinicalTrials.gg
RecruitingNCT04212494Updated Sep 9, 2026

Thrombus Aspiration in STEMI Patients With High Thrombus Burden

An interventional study of Thrombus aspiration and PCI Alone in ST-segment Elevation Myocardial Infarction (STEMI), sponsored by Guangdong Provincial People's Hospital. Recruiting at 50 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Guangdong Provincial People's Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2020; still recruiting 6 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
3,838
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 146 studies in ST Elevation Myocardial Infarction with a site in China — 42 open to participants now, 44 under way, 2 of them phase 3. ST Elevation Myocardial Infarction · China.

Planned enrollment
8th of 97
3,838 · median 320
Started
2020
with 8 others
No phase
51 of 146
21 open now
Primary completion
2026-12
later than 13 of 42 live
Registered
66th of 146
by date

Among the 146 studies in ST Elevation Myocardial Infarction with a site in China, this one is the 8th largest by planned enrollment of the 97 interventional ones, is one of 9 that started in 2020, is one of 51 with no phase, reaches primary completion later than 13 of the 42 other live ones, and was the 66th registered.

By phase

146 studies; the count open now beside each. This study's row is marked.

No phasethis study51 · 21 open
Observational48 · 9 open
Phase 425 · 4 open
Phase 39 · 2 open
Phase 26 · 3 open
Phase 12 · 2 open
Phase 1/22 · 0 open
Phase 2/32 · 0 open
Other kind1 · 1 open

By the year they started

First in 2003; this study’s year is marked. 9 started in 2020.

Size and results

Median enrollment 320 across the 97 interventional studies, 737 across the 48 observational. Of the 39 that completed or were terminated, 1 (3%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 146 studies in ST Elevation Myocardial Infarction with a site in China, or all of them as a file.
02

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.

Read the detailed 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.

03

Conditions studied

  • ST-segment Elevation Myocardial Infarction (STEMI)

Keywords

  • Thrombus Aspiration
  • Coronary Intervention
  • Thrombus Burden
  • ST-segment Elevation Myocardial Infarction
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. must be voluntary;

Exclusion criteria

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 to dual antiplatelet therapy;
  7. Patients were considered unsuitable by other researchers.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3,838 participants (estimated)

Study arms

  • Experimental
    Thrombus aspiration

    Upfront manual thrombus aspiration followed by PCI

    Procedure: Thrombus aspiration

  • Active comparator
    PCI Alone

    PCI without upfront manual thrombus aspiration

    Procedure: PCI Alone

Interventions

  • ProcedureThrombus aspiration

    Percutaneous Coronary Intervention with manual aspiration thrombectomy

  • ProcedurePCI Alone

    Percutaneous Coronary Intervention without manual aspiration thrombectomy

06

What researchers measure

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 days

Secondary 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 days

  2. 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 year

07

Study locations

20 of 50 sites recruiting
  • Fujian Provincial Hospital
    Fuzhou, Fujian 350001, China
    Not yet recruiting
  • First People's Hospital of Foshan
    Foshan, Guangdong 528000, China
    Recruiting
  • The Second People's Hospital of Nanhai District
    Foshan, Guangdong 528251, China
    Recruiting
  • First People's Hospital of Shunde (Affiliated Hospital at Shunde, Southern Medical University)
    Foshan, Guangdong 528300, China
    Recruiting
    • Yunzhao Hu · Contact13702832088
  • Guangdong Provincial People's Hospital
    Guangzhou, Guangdong 510000, China
    Recruiting
  • Guangzhou Panyu Central Hospital
    Guangzhou, Guangdong 510000, China
    Not yet recruiting
    • Jianhao Li · Contact13928838806
  • Guangzhou General Hospital of Guangzhou Military Command
    Guangzhou, Guangdong 510010, China
    Not yet recruiting
  • The first Affiliated Hospital, Sun Yat-Sen University
    Guangzhou, Guangdong 510080, China
    Not yet recruiting
    • Yi Li, MD · Contact13822285813
  • Guangdong Provincial Hospital of traditional Chinese Medicine
    Guangzhou, Guangdong 510120, China
    Not yet recruiting
    • Xia Wang · Contact13825133223
  • The First Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong 510120, China
    Not yet recruiting
  • The Second Affiliated Hospital, Sun Yat-Sen University
    Guangzhou, Guangdong 510235, China
    Not yet recruiting
    • Ruqiong Nie · Contact
  • Zhujiang Hospital of Southern Medical University
    Guangzhou, Guangdong 510280, China
    Not yet recruiting
    • Hua Xiao · Contact13889900264
  • Nanfang Hospital
    Guangzhou, Guangdong 510515, China
    Not yet recruiting
    • Jianping Bin, MD · Contact18680488488
  • Huangpu Division of The First Affiliated Hospital, Sun Yat-sen University
    Guangzhou, Guangdong 510700, China
    Not yet recruiting
    • Qing Xu · Contact13609648852
  • Huadu District People's Hospital of Guangzhou
    Guangzhou, Guangdong 510800, China
    Not yet recruiting
    • Junhui Xiao · Contact15011888377
  • Huizhou Third People's Hospital
    Huizhou, Guangdong 516002, China
    Not yet recruiting
    • Sigan Zhong · Contact13502428918
  • Jiangmen Central Hospital
    Jiangmen, Guangdong 529030, China
    Recruiting
  • Kaiping Central Hospital
    Kaiping, Guangdong 529300, China
    Recruiting
  • Maoming People's Hospital
    Maoming, Guangdong 525000, China
    Not yet recruiting
    • Chunbo Chen, MD · Contact13922745788
  • The Second Affiliated Hospital of Shantou university Medical College
    Shantou, Guangdong 515041, China
    Recruiting
    • Jilin Li, MD · Contact13592852807
  • Yue Bei People's Hospital
    Shaoguan, Guangdong 512026, China
    Recruiting
    • Liangqiu Tang · Contact13509056589
  • Shenzhen People's Hospital
    Shenzhen, Guangdong 518020, China
    Recruiting
  • The Eighth Affiliated Hospital, Sun Yat-Sen University
    Shenzhen, Guangdong 518033, China
    Recruiting
    • Guifu Wu, PD · Contact15989893111
  • Peking University Shenzhen Hospital
    Shenzhen, Guangdong 518035, China
    Not yet recruiting
  • Shenzhen Bao'an District People's Hospital
    Shenzhen, Guangdong 518101, China
    Recruiting
    • Zhiming Shen · Contact13632772238
  • Taishan people's Hospital
    Taishan, Guangdong 529200, China
    Recruiting
    • Yan Chen · Contact13580014030
  • Nanxiong people's Hospital
    Xiongzhou, Guangdong 512400, China
    Recruiting
    • Foyuan Fan · Contact15914844979
  • People's Hospital of Yangjiang City
    Yangjiang, Guangdong 529500, China
    Recruiting
  • The Second Affiliated Hospital of Guangdong Medical University
    Zhanjiang, Guangdong, China
    Not yet recruiting
    • Can Chen · Contact13902502296
  • Sihui people's Hospital
    Zhaoqing, Guangdong 526200, China
    Recruiting
    • Yuehua Huang · Contact13929832932
  • Zhongshan People's Hospital
    Zhongshan, Guangdong 528403, China
    Recruiting
    • Li Feng · Contact
  • The Fifth Affiliated Hospital, Sun Yat-Sen University
    Zhuhai, Guangdong 519000, China
    Not yet recruiting
  • Zhuhai people's Hospital
    Zhuhai, Guangdong 519000, China
    Not yet recruiting
    • Jun Li · Contact13709686461
  • Guilin people's Hospital
    Guilin, Guangxi 541002, China
    Not yet recruiting
    • Bin Li · Contact18978320601
  • The Second Clinical College of Hainan Medical University
    Haikou, Hainan 460106, China
    Not yet recruiting
  • Hainan People's Hospital
    Haikou, Hainan 570311, China
    Not yet recruiting
    • Bin Li · Contact13907698311
  • Wuhan Asia Heart Hospital
    Wuhan, Hubei 430022, China
    Not yet recruiting
  • The Third Xiangya Hospital of Central South University
    Changsha, Hunan 13787318063, China
    Recruiting
  • The Second Xiangya Hospital of Central South University
    Changsha, Hunan 410008, China
    Not yet recruiting
  • GanZhou Municopal Hospital
    Ganzhou, Jiangxi 341000, China
    Not yet recruiting
    • Zhonghan Ni · Contact13889908239
  • Shangyou Hospital
    Ganzhou, Jiangxi 341200, China
    Recruiting
    • Shuo Sun · Contact15018788144
  • Affiliated Hospital, Weifang Medical University
    Weifang, Shandong 261031, China
    Recruiting
    • Jingtian Li · Contact
  • The first Affiliated Hospital of Xi'an Jiaotong University
    Xi’an, Shanxi 710061, China
    Not yet recruiting
    • Ning Guo · Contact13991229101
  • West China Hospital
    Chengdu, Sichuan 610041, China
    Not yet recruiting
  • Sichuan Provincial People's Hospital
    Chengdu, Sichuan 610072, China
    Not yet recruiting
  • Kashgar first people's Hospital
    Kashgar, Xinjiang 844000, China
    Recruiting
    • Yuying Hu · Contact13579061010
  • The First Affilicated Hospital of Xinjiang Medical University
    Ürümqi, Xinjiang 830054, China
    Not yet recruiting
    • Yining Yang, MD · Contact13199860611
  • Yan'an Hospital of Kunming City
    Kunming, Yunnan 65005, China
    Not yet recruiting
    • Qiang Xue, MD · Contact
  • Shaoxing people's Hospital
    Shaoxing, Zhejiang 312000, China
    Not yet recruiting
    • Yangjian Liu · Contact13570786812
  • The First Affiliated Hospital of Wenzhou Medical University
    Wenzhou, Zhejiang 325000, China
    Not yet recruiting
    • Hao Zhou · Contact
08

References and documents

Publications

  • 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. PubMed 6350634 ↗
  • 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. PubMed 7412821 ↗
  • 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. PubMed 17692740 ↗
  • 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. PubMed 12021220 ↗
  • 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. PubMed 16022970 ↗
  • 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. PubMed 18539223 ↗
  • 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. PubMed 23991656 ↗
  • 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. PubMed 25853743 ↗
  • 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. PubMed 26498666 ↗
  • 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. PubMed 27941066 ↗
  • 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. PubMed 28886621 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2020 (actual). Primary completion is estimated for Dec 2026, 76 months after the start.

Of 134 non-industry interventional studies with no phase under ST Elevation Myocardial Infarction, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 64. This study's planned 76 months is above that.

Counting every sponsor, half of 143 studies reached it within 38 months; a quarter within 19 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 24, 2019
First posted
Dec 27, 2019
StartActual
Aug 30, 2020
Primary completionEst.
Dec 31, 2026
CompletionEst.
Apr 30, 2027
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04212494
Collaborators
Zhongshan People's Hospital, Guangdong, China, Kaiping Central Hospital, Second Affiliated Hospital of Shantou University Medical College, The Third Xiangya Hospital of Central South University, Sihui City People's Hospital, Shenzhen Baoan District People's Hospital, People's Hospital of Nanxiong County, Yuebei People's Hospital, Weifang Medical University, Wuzhou Gongren Hospital, Dafeng Hospital of Chaoyang District in Shantou City, Dongguan People's Hospital, Yangchun People's Hospital, Taishan People's Hospital, The Second People's Hospital of Foshan, Guangzhou Hospital of integrated Traditional and West Medicine, Guangning People's Hospital, Foshan Sanshui District People's Hospital, Qingyuan People's Hospital, Luhe County People's Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, The Fourth People's Hospital of Chenzhou, People's Hospital of Dapu County, Shenzhen People's Hospital, Heyuan people's Hospital, Huaiji People's Hospital, People's Hospital of Yingde City, Zhongshan Hospital Of Traditional Chinese Medicine, The Third Affiliated Hospital of Guangzhou Medical University, Lianzhou People's Hospital, Lianping Xian Ren Ming Yi Yuan, Guangxi Zhuang Autonomous Region Nationalities Hospital, Liuzhou Municipal Liutie Central Hospital, Chen Zhou 3RD People's Hospital, Longgang District People's Hospital of Shenzhen, The Affiliated Shunde Hospital of Jinan University, Shenzhen Longhua District Central Hospital, Shantou Central Hospital, Tongxiang First People's Hospital, Bobai County People's Hospital, Guangxi, Meizhou Traditional Chinese Medicine Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Shenzhen Third People's Hospital, Yangjiang People's Hospital, Jiangmen Central Hospital, Eighth Affiliated Hospital, Sun Yat-sen University, The First People's Hospital of Kashgar Erea, First People's Hospital of Foshan, Zhaoqing Gaoyao People's Hospital, People's Hospital of Nanhai District, Foshan, The Second Affiliated Hospital of Dalian Medical University, Nanning Second People's Hospital, The Second People's Hospital of Nanhai District of Foshan, Shangyou People's Hospital, Southern Medical University, China, Chaozhou Central Hospital, Chaoshan Hospital, the First Affiliated Hospital of Jinan University, Shenzhen Baoan District Traditional Chinese Medicine Hospital, The First Affiliated Hospital of Gannan Medical College, Puyang People's Hospital, Tongliao People's Hospital, Luohe Central Hospital, Linying County People's Hospital, Xiaolan People's Hospital of Zhongshan, The First Dongguan Affiliated Hospital of Guangdong Medical University
Responsible party
Sponsor
First posted
Dec 27, 2019
Start date
Aug 30, 2020
Primary completion
Dec 31, 2026 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Sep 9, 2026

Study contacts

Pengcheng He, MD
Contact
drhepengcheng@aliyun.com
86-13829730152

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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