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STEMI - ST Elevation Myocardial InfarctionPhase 3NCT06327659

Efficacy of Using 50 ml Syringe Manual Thrombectomy Catheter in Primary PCI With Heavy Thrombus Burden

A Phase 3 study testing 30 mL syringe manual thrombectomy catheter and 50 mL syringe manual thrombectomy catheter in people with STEMI - ST Elevation Myocardial Infarction and Thrombosis Cardiac, run by Helwan University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In high thrombus burden subgroup of Acute STEMI, manual aspiration thrombectomy was associated with reduced cardiovascular death but increased stroke or transient ischemic attack. The role of aspiration thrombectomy is still a matter of active debate. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
30 mL syringe manual thrombectomy catheter and 50 mL syringe manual thrombectomy catheter
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteEgypt
Study dates
1 Apr 2024to 1 Jan 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with STEMI within 12-24 h of symptom onset in native coronary vessel with heavy thrombus burden (Thrombolysis in Myocardial Infarction [TIMI] thrombus grade 4 or 5 on angiography after the guidewire crossed the target lesion)

Who cannot join

  • Very delayed STEMI presentation.
  • STEMI with low thrombus burden.
  • STEMI with cardiogenic shock.
  • Failed recanalization of culprit vessel.
  • Complex coronary anatomy candidates for coronary artery bypass graft.

Trial locations and contacts

1 site in 1 country.

Arafa Gomaa, MD contact

+201159541000

arafa.gomaa@med.helwan.edu.eg

Egypt1 site

  • Badr University Hospital

    Badr, Cairo Governorate

    Arafa Gomaa, MD

    Arafa Gomaa, MD

Other trials in Egypt

About this study

Official title: Efficacy of Using 50 ml Syringe Manual Thrombectomy Catheter in Patients With Heavy Thrombus Burden Undergoing Primary Percutaneous Coronary Intervention

In high thrombus burden subgroup of Acute STEMI, manual aspiration thrombectomy was associated with reduced cardiovascular death but increased stroke or transient ischemic attack. The role of aspiration thrombectomy is still a matter of active debate. Manual aspiration suffers from decreasing aspiration force as the syringe fills with fluid and requires the operator to exchange syringes during the procedure to maintain suction.

Read the detailed description

Acute ST-segment elevation myocardial infarction (STEMI) poses a major hazard to human life and health due to its high morbidity and deaths. The frequency of STEMI is increasing. Although dual antiplatelet treatment (DAPT) and primary percutaneous coronary intervention (PPCI) have enhanced survival in STEMI suffers during the last 20 years. Complications after myocardial infarction continue to be a major contributor to high mortality and disability.

Treatment focuses on minimizing infarct size by reopening the occluded artery and restoring myocardial perfusion While PPCI is an established treatment option and can reliably re-establish flow, it can also cause distal embolization, resulting in persistent microvascular obstruction and poor myocardial perfusion. Poor myocardial perfusion after PCI is associated with worse left ventricular functional recovery and increased long-term mortality. By removing thrombotic material, aspiration thrombectomy before PCI may reduce the risk of distal embolization and improve myocardial perfusion. A meta-analysis of large randomized trials comparing aspiration thrombectomy and PCI alone found that routine manual aspiration thrombectomy did not improve clinical outcomes. However, in the high thrombus burden subgroup, manual aspiration thrombectomy was associated with reduced cardiovascular death but increased stroke or transient ischemic attack.

For select cardiac populations, particularly those with high thrombus burden, the role of aspiration thrombectomy is still a matter of active debate. Manual aspiration suffers from decreasing aspiration force as the syringe fills with fluid and requires the operator to exchange syringes during the procedure to maintain suction.

Being tested
30 mL syringe manual thrombectomy catheter, 50 mL syringe manual thrombectomy catheter
Keywords
STEMI, heavy thrombus burden, manual thrombectomy, 50 mL syringe
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 30 mL syringe manual thrombectomy catheterDevice

    30 mL syringe manual thrombectomy catheter

  • 50 mL syringe manual thrombectomy catheterDevice

    50 mL syringe manual thrombectomy catheter

Study groups in NCT06327659
Study groupRoleWhat they receive
Group IActive comparatorNot described
Receives: Device: 30 mL syringe manual thrombectomy catheter
Group IIExperimentalNot described
Receives: Device: 50 mL syringe manual thrombectomy catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. TIMI flow grade after PCI

    Thrombolysis in Myocardial Infarction (TIMI) flow grades:

    • Grade 0: There is no antegrade flow or perfusion beyond the blockage.
    • Grade 1 indicates that the contrast material was able to flow through the blockage during the cineangiographic recording series without totally obstructing the coronary bed distal to the obstruction.
    • Grade 2: The coronary artery distal to the occlusion is opacified by the contrast material at a much slower pace than in regions unaffected by the prior closure.
    • Grade 3: indicates contrast material is cleared from the affected bed at the same rate as it is cleared from an unaffected bed in the same or opposite artery.

    Measured: During procedure

  2. MBG after PCI

    Myocardial blush grade (MBG):

    • Grade 0: No myocardial blush or contrast density.
    • Grade 1: Minimal myocardial blush or contrast density.
    • Grade 2: Moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral non-infarct-related coronary artery.
    • Grade 3: Normal myocardial blush or contrast density comparable with that obtained during angiography of a contralateral or ipsilateral non-infarct-related coronary artery.

    Measured: During procedure

Secondary outcomes (6)

  1. Composite rate of occurrence of MACE

    composite of cardiovascular death, recurrent myocardial infarction, stroke, cardiogenic shock, or new or worsening New York Heart Association class IV heart failure

    Measured: 30 days after PCI

  2. Rate of cardiovascular death

    Measured: 30 days after PCI

  3. Rate of recurrent myocardial infarction

    Measured: 30 days after PCI

  4. Rate of stroke

    Measured: 30 days after PCI

  5. Rate of cardiogenic shock

    Measured: 30 days after PCI

  6. Rate of NYHA IV heart failure

    New or worsening New York Heart Association class IV heart failure

    Measured: 30 days after PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2024
  2. Study start1 Apr 2024 (estimated)
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion1 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06327659
Sponsor's protocol ID
Thrombectomy by 50 ml syringe
Status last verified
Mar 2024
First submitted
18 Mar 2024
Last updated
26 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Barbur MCM, Martinez-Avila MC, Madero AI, Nunez JFG, Dominguez JCG. Acute ST-segment elevation myocardial infarction: to be or not to be? Arch Clin Cases. 2022 Apr 6;9(1):19-23. doi: 10.22551/2022.34.0901.10198. eCollection 2022.

    PubMed 35529096

  • Zalewski J, Nowak K, Furczynska P, Zalewska M. Complicating Acute Myocardial Infarction. Current Status and Unresolved Targets for Subsequent Research. J Clin Med. 2021 Dec 16;10(24):5904. doi: 10.3390/jcm10245904.

    PubMed 34945202

  • Anderson JL, Morrow DA. Acute Myocardial Infarction. N Engl J Med. 2017 May 25;376(21):2053-2064. doi: 10.1056/NEJMra1606915. No abstract available.

    PubMed 28538121

  • O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, 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, Anderson JL, Jacobs AK, Halperin JL, Albert NM, Brindis RG, Creager MA, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Kushner FG, Ohman EM, Stevenson WG, Yancy CW; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013 Jan 29;127(4):e362-425. doi: 10.1161/CIR.0b013e3182742cf6. Epub 2012 Dec 17. No abstract available.

    PubMed 23247304

  • Henriques JP, Zijlstra F, Ottervanger JP, de Boer MJ, van 't Hof AW, Hoorntje JC, Suryapranata H. Incidence and clinical significance of distal embolization during primary angioplasty for acute myocardial infarction. Eur Heart J. 2002 Jul;23(14):1112-7. doi: 10.1053/euhj.2001.3035.

    PubMed 12090749

  • Mathews SJ, Parikh SA, Wu W, Metzger DC, Chambers JW, Ghali MGH, Sumners MJ, Kolski BC, Pinto DS, Dohad S. Sustained Mechanical Aspiration Thrombectomy for High Thrombus Burden Coronary Vessel Occlusion: The Multicenter CHEETAH Study. Circ Cardiovasc Interv. 2023 Feb;16(2):e012433. doi: 10.1161/CIRCINTERVENTIONS.122.012433. Epub 2023 Feb 21.

    PubMed 36802804

  • Jolly SS, Cairns JA, Lavi S, Cantor WJ, Bernat I, Cheema AN, Moreno R, Kedev S, Stankovic G, Rao SV, Meeks B, Chowdhary S, Gao P, Sibbald M, Velianou JL, Mehta SR, Tsang M, Sheth T, Dzavik V; TOTAL Investigators. Thrombus Aspiration in Patients With High Thrombus Burden in the TOTAL Trial. J Am Coll Cardiol. 2018 Oct 2;72(14):1589-1596. doi: 10.1016/j.jacc.2018.07.047.

    PubMed 30261959

  • Kobkitsuksakul C, Jaroenngarmsamer T. Comparison of vacuum pressure syringe aspiration technique with penumbra aspiration thrombectomy system: an in vitro study. Hong Kong J Radiol 2021; 24:47-

  • Weinsaft JW, Kim J, Medicherla CB, Ma CL, Codella NC, Kukar N, Alaref S, Kim RJ, Devereux RB. Echocardiographic Algorithm for Post-Myocardial Infarction LV Thrombus: A Gatekeeper for Thrombus Evaluation by Delayed Enhancement CMR. JACC Cardiovasc Imaging. 2016 May;9(5):505-15. doi: 10.1016/j.jcmg.2015.06.017. Epub 2015 Oct 14.

    PubMed 26476503

  • Lashin H, Olusanya O, Smith A, Bhattacharyya S. Left Ventricular Ejection Fraction Correlation With Stroke Volume as Estimated by Doppler Echocardiography in Cardiogenic Shock: A Retrospective Observational Study. J Cardiothorac Vasc Anesth. 2022 Sep;36(9):3511-3516. doi: 10.1053/j.jvca.2022.05.009. Epub 2022 May 10.

    PubMed 35662515

  • Lee OH, Kim Y, Son NH, Roh JW, Im E, Cho DK, Choi D. Comparison of Distal Radial, Proximal Radial, and Femoral Access in Patients with ST-Elevation Myocardial Infarction. J Clin Med. 2021 Aug 2;10(15):3438. doi: 10.3390/jcm10153438.

    PubMed 34362221

  • Suleiman S, Coughlan JJ, Arockiam S, Arnous S, Kiernan TJ. Pre-Percutaneous Coronary Intervention TIMI Flow Grade in STEMI Patients Treated with Pre-Hospital Ticagrelor Loading. Ir Med J. 2022 Mar 16;115(3):564.

    PubMed 35532897

  • Gibson CM, de Lemos JA, Murphy SA, Marble SJ, McCabe CH, Cannon CP, Antman EM, Braunwald E; TIMI Study Group. Combination therapy with abciximab reduces angiographically evident thrombus in acute myocardial infarction: a TIMI 14 substudy. Circulation. 2001 May 29;103(21):2550-4. doi: 10.1161/01.cir.103.21.2550.

    PubMed 11382722

  • Gibson CM, Cannon CP, Murphy SA, Ryan KA, Mesley R, Marble SJ, McCabe CH, Van De Werf F, Braunwald E. Relationship of TIMI myocardial perfusion grade to mortality after administration of thrombolytic drugs. Circulation. 2000 Jan 18;101(2):125-30. doi: 10.1161/01.cir.101.2.125.

    PubMed 10637197

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 30 mL syringe manual thrombectomy catheter and 50 mL syringe manual thrombectomy catheter in people with STEMI - ST Elevation Myocardial Infarction and Thrombosis Cardiac, run by Helwan University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Arafa Gomaa, MD (+201159541000, arafa.gomaa@med.helwan.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TIMI flow grade after PCI (time frame: During procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06327659, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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