Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT01472718
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2011-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Thromboaspiration in Patients With High Thrombotic Burden Undergoing Primary Percutaneous Coronary Intervention (PCI)
Sponsor:
Organization:
Raw JSON
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thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)', 'otherNumAtRisk': 104, 'deathsNumAtRisk': 104, 'otherNumAffected': 0, 'seriousNumAtRisk': 104, 'deathsNumAffected': 2, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Complete ST-segment Elevation Resolution at 60 Minutes After the End of the Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Primary Coronary Intervention', 'description': 'standard primary PCI (with stenting, as required): standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices'}, {'id': 'OG001', 'title': 'Coronary Thrombectomy', 'description': 'coronary thrombectomy: coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 minutes after the end of the procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Infarct Size as Assessed by Delayed-enhancement Cardiac Magnetic Resonance Imaging (DE-MRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Primary Coronary Intervention', 'description': 'standard primary PCI (with stenting, as required): standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices'}, {'id': 'OG001', 'title': 'Coronary Thrombectomy', 'description': 'coronary thrombectomy: coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)'}], 'classes': [{'categories': [{'measurements': [{'value': '19.3', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '20.4', 'spread': '10.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months after the index procedure', 'unitOfMeasure': '% of LV mass', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Primary Coronary Intervention', 'description': 'standard primary PCI (with stenting, as required): standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices'}, {'id': 'FG001', 'title': 'Coronary Thrombectomy', 'description': 'coronary thrombectomy: coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Primary Coronary Intervention', 'description': 'standard primary PCI (with stenting, as required): standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices'}, {'id': 'BG001', 'title': 'Coronary Thrombectomy', 'description': 'coronary thrombectomy: coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000', 'lowerLimit': '54', 'upperLimit': '70'}, {'value': '63', 'groupId': 'BG001', 'lowerLimit': '53', 'upperLimit': '71'}, {'value': '62', 'groupId': 'BG002', 'lowerLimit': '53', 'upperLimit': '70'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'coronary TIMI frame count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '86', 'spread': '28', 'groupId': 'BG000'}, {'value': '95', 'spread': '17', 'groupId': 'BG001'}, {'value': '91', 'spread': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'frames', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-21', 'studyFirstSubmitDate': '2011-11-13', 'resultsFirstSubmitDate': '2019-01-21', 'studyFirstSubmitQcDate': '2011-11-15', 'lastUpdatePostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-21', 'studyFirstPostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Complete ST-segment Elevation Resolution at 60 Minutes After the End of the Procedure', 'timeFrame': '60 minutes after the end of the procedure'}, {'measure': 'Infarct Size as Assessed by Delayed-enhancement Cardiac Magnetic Resonance Imaging (DE-MRI)', 'timeFrame': '3 months after the index procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Primary PCI for STEMI']}, 'referencesModule': {'references': [{'pmid': '23257370', 'type': 'DERIVED', 'citation': 'De Carlo M, Aquaro GD, Palmieri C, Guerra E, Misuraca L, Giannini C, Lombardi M, Berti S, Petronio AS. A prospective randomized trial of thrombectomy versus no thrombectomy in patients with ST-segment elevation myocardial infarction and thrombus-rich lesions: MUSTELA (MUltidevice Thrombectomy in Acute ST-Segment ELevation Acute Myocardial Infarction) trial. JACC Cardiovasc Interv. 2012 Dec;5(12):1223-30. doi: 10.1016/j.jcin.2012.08.013.'}]}, 'descriptionModule': {'briefSummary': '200 consecutive patients presenting with STEMI within 12 hours from the onset of symptoms and having a high thrombotic burden at coronary angiography, defined as the presence of a thrombus size ≥ 2 times the diameter of the vessel, according to a visual estimate. The main objective of the study is to evaluate the effectiveness of thrombectomy (either rheolytic or manual aspiration) as an adjunct to primary or rescue angioplasty, in patients with angiographic evidence high thrombotic burden in the culprit artery. Primary end points: (1) rate of complete ST-segment elevation resolution at 60 minutes after the end of the procedure; (2) infarct size as assessed by delayed-enhancement cardiac magnetic resonance imaging (DE-MRI) at 3 months after the index procedure.\n\nSecondary endpoints: post-procedural TIMI flow grade; post-procedural MBG; infarct transmurality at 3 months; MVO at 3 months; 1-year actuarial freedom from MACEs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Prolonged, continuous signs and symptoms of ischemia lasting more than 20 min, starting within 12 hours prior to randomization, and ST elevation ≥ 2mm in ≥2 contiguous ECG leads, or new left bundle branch block (LBBB)\n2. Presence of high thrombotic burden in the culprit lesion at diagnostic angiography (defined as the presence of a thrombus size ≥ 2 times the diameter of the vessel, according to a visual estimate, or abrupt cut-off occlusion of a coronary artery ≥3 mm in reference vessel diameter)\n3. Written informed consent\n\nExclusion Criteria:\n\n* Low-risk (ST elevation in ≤2 leads) inferior AMI\n* Previous infarction in the same area (assessed by ECG)\n* PCI in the 2 weeks prior to AMI\n* Active internal bleeding\n* History of cerebrovascular accident in the previous 2 years or cerebrovascular accident with a significant residual neurological deficit\n* Head or spine surgery or trauma in the previous 2 months\n* Recent (within six weeks) gastrointestinal (GI) or genitourinary (GU) bleeding of clinical significance\n* Administration of oral anticoagulants within seven days unless prothrombin time is \\<1.2 times control\n* Bleeding diathesis or severe uncontrolled arterial hypertension\n* Thrombocytopenia (\\<100 000 cells/mL)\n* Recent (within six weeks) major surgery or trauma\n* Intracranial neoplasm, arteriovenous malformation, or aneurysm\n* Severe renal or liver failure\n* Allergy to aspirin\n* Contraindication to MRI examination\n* Pregnancy and lactation'}, 'identificationModule': {'nctId': 'NCT01472718', 'briefTitle': 'Thromboaspiration in Patients With High Thrombotic Burden Undergoing Primary Percutaneous Coronary Intervention (PCI)', 'organization': {'class': 'OTHER', 'fullName': 'University of Pisa'}, 'officialTitle': 'Efficacy of Thromboaspiration in Patients With High Thrombotic Burden Undergoing Primary Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'UP-DCT-201001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard primary coronary intervention', 'interventionNames': ['Device: standard primary PCI (with stenting, as required)']}, {'type': 'EXPERIMENTAL', 'label': 'coronary thrombectomy', 'interventionNames': ['Device: coronary thrombectomy']}], 'interventions': [{'name': 'coronary thrombectomy', 'type': 'DEVICE', 'description': 'coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)', 'armGroupLabels': ['coronary thrombectomy']}, {'name': 'standard primary PCI (with stenting, as required)', 'type': 'DEVICE', 'description': 'standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices', 'armGroupLabels': ['standard primary coronary intervention']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pisa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Cardiac Catheterization Laboratory, University of Pisa, Azienda Ospedaliero-Universitaria Pisana', 'investigatorFullName': 'Prof. Anna Sonia Petronio', 'investigatorAffiliation': 'University of Pisa'}}}}