Efficacy of Thrombus Aspiration in Patients With Acute ST-Segment Elevation Myocardial Infarction: A Prospective, Multicenter, Randomized, Controlled, Single-Blind Clinical Trial

NCT07551700 | Not Yet Recruiting DMC

• 1 other identifier: TRAP-MI
• Study Type: interventional
• Target: 6,760
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if adding standardized manual thrombus aspiration to primary percutaneous coronary intervention (PPCI) works better to improve heart health outcomes and protect long-term heart function in adults with acute ST-segment elevation myocardial infarction (STEMI) and a high blood clot burden in the heart's arteries. The main questions it aims to answer are:

• Does PPCI plus manual thrombus aspiration lower the risk of serious heart problems one year after treatment, compared to PPCI alone?
• Can manual thrombus aspiration better protect long-term heart function in people with a high blood clot burden? Researchers will compare two groups of participants-one group getting PPCI plus manual thrombus aspiration and one group getting only PPCI-to see if the aspiration treatment leads to fewer serious heart problems, better long-term heart function, and similar safety (including no higher risk of stroke). Participants will:
• Have a heart artery scan (coronary angiography) to confirm a high blood clot burden
• Be randomly assigned to one of the two treatment groups for their PPCI procedure
• Complete follow-up checks at 30 days, 6 months, and 1 year after treatment, including heart function tests (like echocardiograms)
• Have heart magnetic resonance (CMR) scans if selected, to measure heart tissue damage and heart function
• Have their heart health status and any adverse events recorded throughout the study

Conditions

ST-segment Elevation Myocardial Infarction (STEMI)

Keywords

Acute ST-Segment Elevation Myocardial Infarction; STEMI; Thrombus Aspiration; Primary Percutaneous Coronary Intervention; PPCI; High Thrombus Burden; Randomized Controlled Trial; Multicenter Trial

Outcome Measures

Primary Outcomes (1)

• Composite major adverse cardiovascular events (MACEs) at 1 year after the procedure

  The primary outcome is the cumulative incidence of composite MACEs, including four components: cardiovascular death, recurrent myocardial infarction, target vessel revascularization (TVR), and rehospitalization for heart failure.

  1 year post-procedure

Secondary Outcomes (10)

• Composite MACEs at 180 days after the procedure

  180 days post-procedure

• Composite major adverse cardiovascular and cerebrovascular events (MACCEs) at 30 days after the procedure

  30 days post-procedure

• Immediate TIMI flow grade after PCI

  Immediate post-procedure (PCI completion)

• Immediate ST-segment resolution (STR) rate after PCI

  Immediate post-procedure (PCI completion)

• Myocardial Blush Grade (MBG) after PCI

  Immediate post-procedure (PCI completion)

Study Arms (2)

PPCI + Manual Thrombus Aspiration

EXPERIMENTAL

Manual thrombus aspiration with the designated aspiration catheter will be performed prior to stent implantation.

Procedure: Manual Thrombus Aspiration; Procedure: Primary Percutaneous Coronary Intervention (PPCI)

PPCI alone

ACTIVE COMPARATOR

Routine balloon dilation and stent implantation will be performed without prior thrombus aspiration.

Procedure: Primary Percutaneous Coronary Intervention (PPCI)

Interventions

Manual Thrombus Aspiration PROCEDURE

Manual thrombus aspiration is an adjunct to primary percutaneous coronary intervention (PPCI) for acute ST-segment elevation myocardial infarction (STEMI) patients with angiographically confirmed high thrombus burden (TIMI thrombus grade ≥3 or floating thrombus). Performed before stent implantation on the infarct-related vessel, the procedure uses a study-designated modern 6Fr-compatible manual aspiration catheter, with a 50ml large-volume locked syringe for stable negative pressure and heparinized normal saline for catheter flushing. Under fluoroscopy, the catheter is advanced 1-2cm distal to the thrombus, then retracted at a uniform speed of 1cm/sec with continuous negative pressure. Aspiration can be repeated up to 3 times if needed; successful aspiration is confirmed by visible thrombotic material and improved angiographic findings. No bailout aspiration is performed for failed cases, which proceed directly to routine balloon dilation and stent implantation.

Also known as: Manual Aspiration Thrombectomy

PPCI + Manual Thrombus Aspiration

Primary Percutaneous Coronary Intervention (PPCI) PROCEDURE

Standard primary percutaneous coronary intervention with balloon dilation and stent implantation for STEMI

PPCI + Manual Thrombus Aspiration; PPCI alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years old, diagnosed with acute ST-segment elevation myocardial infarction (STEMI) (chest pain plus ST-segment elevation ≥1mm or new-onset left bundle branch block \[LBBB\]) with symptom onset \< 12 hours.
• Planned to undergo primary percutaneous coronary intervention (PPCI).
• High thrombus burden in the target vessel (TIMI thrombus grade ≥3, or visible floating thrombus) confirmed by coronary angiography.
• Reference diameter of the target vessel ≥2.75mm, with the lesion suitable for the passage of an aspiration catheter.
• Provided written informed consent to participate in the study.

You may not qualify if:

• Cardiogenic shock (Killip class IV) or requiring mechanical circulatory support.
• A history of previous coronary artery bypass grafting (CABG).
• Concurrent intervention required for non-culprit vessels.
• Severe bleeding tendency (e.g., INR \> 2.5, platelet count \< 50×10⁹/L).
• Severe renal insufficiency (estimated glomerular filtration rate \[eGFR\] \< 30 ml/min/1.73m²).
• Expected survival time \< 1 year (e.g., advanced malignant tumor).

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Related Publications (8)

• 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.

  PMID: 27941066 BACKGROUND

• Rao SV, O'Donoghue ML, Ruel M, Rab T, Tamis-Holland JE, Alexander JH, Baber U, Baker H, Cohen MG, Cruz-Ruiz M, Davis LL, de Lemos JA, DeWald TA, Elgendy IY, Feldman DN, Goyal A, Isiadinso I, Menon V, Morrow DA, Mukherjee D, Platz E, Promes SB, Sandner S, Sandoval Y, Schunder R, Shah B, Stopyra JP, Talbot AW, Taub PR, Williams MS. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025 Apr;151(13):e771-e862. doi: 10.1161/CIR.0000000000001309. Epub 2025 Feb 27.

  PMID: 40014670 BACKGROUND

• Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.

  PMID: 37622654 BACKGROUND

• Jolly SS, Cairns JA, Yusuf S, Rokoss MJ, Gao P, Meeks B, Kedev S, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemela K, Bernat I, Cantor WJ, Cheema AN, Steg PG, Welsh RC, Sheth T, Bertrand OF, Avezum A, Bhindi R, Natarajan MK, Horak D, Leung RC, Kassam S, Rao SV, El-Omar M, Mehta SR, Velianou JL, Pancholy S, Dzavik V; TOTAL Investigators. Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial. Lancet. 2016 Jan 9;387(10014):127-35. doi: 10.1016/S0140-6736(15)00448-1. Epub 2015 Oct 22.

  PMID: 26474811 BACKGROUND

• 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.

  PMID: 23991656 BACKGROUND

• 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.

  PMID: 18539223 BACKGROUND

• Mahmoud KD, Zijlstra F. Thrombus aspiration in acute myocardial infarction. Nat Rev Cardiol. 2016 Jul;13(7):418-28. doi: 10.1038/nrcardio.2016.38. Epub 2016 Mar 10.

  PMID: 26961064 BACKGROUND

• Keeley EC, Hillis LD. Primary PCI for myocardial infarction with ST-segment elevation. N Engl J Med. 2007 Jan 4;356(1):47-54. doi: 10.1056/NEJMct063503. No abstract available.

  PMID: 17202455 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multicenter, randomized, controlled, single-blind, superiority interventional study. Eligible patients with ST-segment elevation myocardial infarction (STEMI) and high thrombus burden are randomly assigned 1:1 to the experimental group (primary percutaneous coronary intervention \[PPCI\] plus standardized manual thrombus aspiration) or the active comparator group (PPCI alone). Outcomes are assessed by blinded endpoint adjudicators and core laboratory personnel, with systematic follow-up for 1 year post-procedure.

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-02