Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-25 @ 11:20 PM
Study NCT ID:
NCT06327659
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Using 50 ml Syringe Manual Thrombectomy Catheter in Primary PCI With Heavy Thrombus Burden
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-23', 'studyFirstSubmitDate': '2024-03-18', 'studyFirstSubmitQcDate': '2024-03-18', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TIMI flow grade after PCI', 'timeFrame': 'During procedure', 'description': 'Thrombolysis in Myocardial Infarction (TIMI) flow grades:\n\n* Grade 0: There is no antegrade flow or perfusion beyond the blockage.\n* 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.\n* 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.\n* 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.'}, {'measure': 'MBG after PCI', 'timeFrame': 'During procedure', 'description': 'Myocardial blush grade (MBG):\n\n* Grade 0: No myocardial blush or contrast density.\n* Grade 1: Minimal myocardial blush or contrast density.\n* 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.\n* Grade 3: Normal myocardial blush or contrast density comparable with that obtained during angiography of a contralateral or ipsilateral non-infarct-related coronary artery.'}], 'secondaryOutcomes': [{'measure': 'Composite rate of occurrence of MACE', 'timeFrame': '30 days after PCI', 'description': 'composite of cardiovascular death, recurrent myocardial infarction, stroke, cardiogenic shock, or new or worsening New York Heart Association class IV heart failure'}, {'measure': 'Rate of cardiovascular death', 'timeFrame': '30 days after PCI'}, {'measure': 'Rate of recurrent myocardial infarction', 'timeFrame': '30 days after PCI'}, {'measure': 'Rate of stroke', 'timeFrame': '30 days after PCI'}, {'measure': 'Rate of cardiogenic shock', 'timeFrame': '30 days after PCI'}, {'measure': 'Rate of NYHA IV heart failure', 'timeFrame': '30 days after PCI', 'description': 'New or worsening New York Heart Association class IV heart failure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['STEMI', 'heavy thrombus burden', 'manual thrombectomy', '50 mL syringe'], 'conditions': ['STEMI - ST Elevation Myocardial Infarction', 'Thrombosis Cardiac']}, 'referencesModule': {'references': [{'pmid': '35529096', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '34945202', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28538121', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23247304', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '12090749', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '36802804', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30261959', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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-'}, {'pmid': '26476503', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '35662515', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '34362221', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '35532897', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11382722', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10637197', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nTreatment 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.\n\nFor 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n\nExclusion Criteria:\n\n* Very delayed STEMI presentation.\n* STEMI with low thrombus burden.\n* STEMI with cardiogenic shock.\n* Failed recanalization of culprit vessel.\n* Complex coronary anatomy candidates for coronary artery bypass graft.'}, 'identificationModule': {'nctId': 'NCT06327659', 'briefTitle': 'Efficacy of Using 50 ml Syringe Manual Thrombectomy Catheter in Primary PCI With Heavy Thrombus Burden', 'organization': {'class': 'OTHER', 'fullName': 'Helwan University'}, 'officialTitle': 'Efficacy of Using 50 ml Syringe Manual Thrombectomy Catheter in Patients With Heavy Thrombus Burden Undergoing Primary Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'Thrombectomy by 50 ml syringe'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I', 'interventionNames': ['Device: 30 mL syringe manual thrombectomy catheter']}, {'type': 'EXPERIMENTAL', 'label': 'Group II', 'interventionNames': ['Device: 50 mL syringe manual thrombectomy catheter']}], 'interventions': [{'name': '30 mL syringe manual thrombectomy catheter', 'type': 'DEVICE', 'description': '30 mL syringe manual thrombectomy catheter', 'armGroupLabels': ['Group I']}, {'name': '50 mL syringe manual thrombectomy catheter', 'type': 'DEVICE', 'description': '50 mL syringe manual thrombectomy catheter', 'armGroupLabels': ['Group II']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Badr', 'state': 'Cairo Governorate', 'country': 'Egypt', 'contacts': [{'name': 'Arafa Gomaa, MD', 'role': 'CONTACT'}, {'name': 'Arafa Gomaa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Badr University Hospital', 'geoPoint': {'lat': 30.136, 'lon': 31.715}}], 'centralContacts': [{'name': 'Arafa Gomaa, MD', 'role': 'CONTACT', 'email': 'arafa.gomaa@med.helwan.edu.eg', 'phone': '+201159541000'}], 'overallOfficials': [{'name': 'Arafa Gomaa, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Helwan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helwan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiology consultant', 'investigatorFullName': 'Arafa Gomaa', 'investigatorAffiliation': 'Helwan University'}}}}