Efficacy of Using 50 ml Syringe Manual Thrombectomy Catheter in Primary PCI With Heavy Thrombus Burden
NCT ID: NCT06327659
Last Updated: 2024-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
88 participants
INTERVENTIONAL
2024-04-01
2025-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group I
30 mL syringe manual thrombectomy catheter
30 mL syringe manual thrombectomy catheter
Group II
50 mL syringe manual thrombectomy catheter
50 mL syringe manual thrombectomy catheter
Interventions
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30 mL syringe manual thrombectomy catheter
30 mL syringe manual thrombectomy catheter
50 mL syringe manual thrombectomy catheter
50 mL syringe manual thrombectomy catheter
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* STEMI with low thrombus burden.
* STEMI with cardiogenic shock.
* Failed recanalization of culprit vessel.
* Complex coronary anatomy candidates for coronary artery bypass graft.
18 Years
ALL
No
Sponsors
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Helwan University
OTHER
Responsible Party
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Arafa Gomaa
Cardiology consultant
Principal Investigators
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Arafa Gomaa, MD
Role: STUDY_DIRECTOR
Helwan University
Locations
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Badr University Hospital
Badr, Cairo Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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Arafa Gomaa, MD
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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Other Identifiers
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Thrombectomy by 50 ml syringe
Identifier Type: -
Identifier Source: org_study_id
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