Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2026-02-28 @ 11:20 AM
Study NCT ID:
NCT05318092
Status:
COMPLETED
Last Update Posted:
2024-07-19
First Post:
2022-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'liz.manning@angiodynamics.com', 'phone': '339-237-2765', 'title': 'Elizabeth Manning', 'organization': 'AngioDynamics, Inc.'}, 'certainAgreement': {'otherDetails': 'The publication of the results from any single site experience within the study is not allowed until the preparation and publication of the multi-center results. Exceptions to this rule require the prior written approval of the Sponsor. If after 180 days from the conclusion of the study, the Sponsor has not published the results, the investigators may publish without prior approval from the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '30 days (+/- 7 days) post-procedure', 'eventGroups': [{'id': 'EG000', 'title': 'AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System', 'description': "AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System", 'otherNumAtRisk': 122, 'deathsNumAtRisk': 122, 'otherNumAffected': 9, 'seriousNumAtRisk': 122, 'deathsNumAffected': 0, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular access site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Staphylococcus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Right Ventricle to Left Ventricle (RV/LV) Ratio Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System', 'description': "AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System"}], 'classes': [{'categories': [{'measurements': [{'value': '-0.45', 'spread': '0.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 48 hours post-procedure', 'description': "Change in Right Ventricle to Left Ventricle (RV/LV) ratio between baseline and 48 hours post-procedure assessed by Computed Tomography Angiography (CTA) and read by the study's core lab.", 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified As Treated population - all subjects who met the inclusion/exclusion criteria of the study and in whom the AlphaVac MMA F1885 cannula was placed within the jugular or one of the common femoral veins, who did not receive thrombolytics during the index procedure.'}, {'type': 'PRIMARY', 'title': 'Rate of Major Adverse Events (MAEs) Within 48 Hours After the Index Procedure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System', 'description': "AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System"}], 'classes': [{'categories': [{'title': 'Subjects experiencing a MAE', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Subjects not experiencing a MAE', 'measurements': [{'value': '117', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 48 hours post-procedure', 'description': 'Rate of Major Adverse Events (MAEs) within the first 48 hours after the index procedure, defined as:\n\nDevice-related death Major bleeding\n\nDevice-related SAEs of:\n\n* Clinical Deterioration\n* Pulmonary Vascular Injury\n* Cardiac Injury', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated population - all subjects who met the inclusion/exclusion criteria of the study and in whom the AlphaVac MMA F1885 cannula was placed within the jugular or one of the common femoral veins.'}, {'type': 'SECONDARY', 'title': 'Use of Thrombolytics Within 48 Hours of the Procedure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System', 'description': "AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System"}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 48 hours of the procedure', 'description': 'Use of thrombolytics within 48 hours of the procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified As Treated population'}, {'type': 'SECONDARY', 'title': 'Length of Stay in the Intensive Care Unit (ICU)/Hospital Within 30 Days Post-procedure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System', 'description': "AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System"}], 'classes': [{'title': 'Length of Stay in ICU', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'Length of Stay in Hospital', 'categories': [{'measurements': [{'value': '5.2', 'spread': '3.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 30 days of the procedure', 'description': 'Length of stay in the Intensive care unit (ICU)/Hospital within 30 days post-procedure.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified As Treated population - all subjects who met the inclusion/exclusion criteria of the study and in whom the AlphaVac MMA F1885 cannula was placed within the jugular or one of the common femoral veins, who did not receive thrombolytics during the index procedure.'}, {'type': 'SECONDARY', 'title': 'Change in Modified Miller Index Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System', 'description': "AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System"}], 'classes': [{'categories': [{'measurements': [{'value': '-5.6', 'spread': '4.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 48 hours post-procedure', 'description': "Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by Computed Tomography Angiography (CTA) and read by the study's core lab. Modified Miller Index ranges from 0 - 16 (higher values mean higher thrombus burden) and a greater negative change is a better outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified As Treated population - all subjects who met the inclusion/exclusion criteria of the study and in whom the AlphaVac MMA F1885 cannula was placed within the jugular or one of the common femoral veins, who did not receive thrombolytics during the index procedure.'}, {'type': 'SECONDARY', 'title': 'Rate of Device Related Complications Including Clinical Deterioration, Cardiac Injury, Pulmonary Vascular Injury, Major Bleeding, and Device-related Death Within 48 Hours of the Index Procedure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System', 'description': "AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System"}], 'classes': [{'title': 'Device-related clinical deterioration', 'categories': [{'title': 'Subjects with event', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Subjects without event', 'measurements': [{'value': '121', 'groupId': 'OG000'}]}]}, {'title': 'Device-related pulmonary vascular injury', 'categories': [{'title': 'Subjects with event', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Subjects without event', 'measurements': [{'value': '121', 'groupId': 'OG000'}]}]}, {'title': 'Device-related cardiac injury', 'categories': [{'title': 'Subjects with event', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Subjects without event', 'measurements': [{'value': '121', 'groupId': 'OG000'}]}]}, {'title': 'Major bleeding', 'categories': [{'title': 'Subjects with event', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Subjects without event', 'measurements': [{'value': '117', 'groupId': 'OG000'}]}]}, {'title': 'Device-related death', 'categories': [{'title': 'Subjects with event', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Subjects without event', 'measurements': [{'value': '122', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 48 hours of the procedure', 'description': 'Rate of device related complications including clinical deterioration, cardiac injury, pulmonary vascular injury, major bleeding, and device-related death within 48 hours of the index procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated population - all subjects who met the inclusion/exclusion criteria of the study and in whom the AlphaVac MMA F1885 cannula was placed within the jugular or one of the common femoral veins.'}, {'type': 'SECONDARY', 'title': 'Rate of Device-related Serious Adverse Events (SAEs) and Death for Any Cause Within 30 Days Post-procedure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System', 'description': "AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System"}], 'classes': [{'title': 'Device-related SAEs', 'categories': [{'title': 'Subjects with event', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Subjects without event', 'measurements': [{'value': '118', 'groupId': 'OG000'}]}]}, {'title': 'Death for any cause', 'categories': [{'title': 'Subjects with event', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Subjects without event', 'measurements': [{'value': '122', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days of the procedure', 'description': 'Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post-procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated population - all subjects who met the inclusion/exclusion criteria of the study and in whom the AlphaVac MMA F1885 cannula was placed within the jugular or one of the common femoral veins.'}, {'type': 'SECONDARY', 'title': 'Symptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System', 'description': "AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System"}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days of the procedure', 'description': 'Symptomatic PE recurrence within 30 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated population - all subjects who met the inclusion/exclusion criteria of the study and in whom the AlphaVac MMA F1885 cannula was placed within the jugular or one of the common femoral veins - who completed the study through 30 days (n=118).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System', 'description': "AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System', 'description': "AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System"}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.9', 'spread': '14.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '113', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '84', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Right Ventricle to Left Ventricle (RV/LV) Ratio', 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '0.31', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Core lab-adjudicated baseline Right Ventricle to Left Ventricle (RV/LV) ratio', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'As Treated Population - all subjects who met the inclusion/exclusion criteria of the study and in whom the AlphaVac MMA F1885 cannula was placed within the jugular or one of the common femoral veins.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-07', 'size': 1641545, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-01T20:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-18', 'studyFirstSubmitDate': '2022-03-24', 'resultsFirstSubmitDate': '2024-05-01', 'studyFirstSubmitQcDate': '2022-03-31', 'lastUpdatePostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-18', 'studyFirstPostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Right Ventricle to Left Ventricle (RV/LV) Ratio Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA)', 'timeFrame': 'At 48 hours post-procedure', 'description': "Change in Right Ventricle to Left Ventricle (RV/LV) ratio between baseline and 48 hours post-procedure assessed by Computed Tomography Angiography (CTA) and read by the study's core lab."}, {'measure': 'Rate of Major Adverse Events (MAEs) Within 48 Hours After the Index Procedure.', 'timeFrame': 'Within 48 hours post-procedure', 'description': 'Rate of Major Adverse Events (MAEs) within the first 48 hours after the index procedure, defined as:\n\nDevice-related death Major bleeding\n\nDevice-related SAEs of:\n\n* Clinical Deterioration\n* Pulmonary Vascular Injury\n* Cardiac Injury'}], 'secondaryOutcomes': [{'measure': 'Use of Thrombolytics Within 48 Hours of the Procedure.', 'timeFrame': 'Within 48 hours of the procedure', 'description': 'Use of thrombolytics within 48 hours of the procedure.'}, {'measure': 'Length of Stay in the Intensive Care Unit (ICU)/Hospital Within 30 Days Post-procedure.', 'timeFrame': 'Within 30 days of the procedure', 'description': 'Length of stay in the Intensive care unit (ICU)/Hospital within 30 days post-procedure.'}, {'measure': 'Change in Modified Miller Index Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA).', 'timeFrame': 'At 48 hours post-procedure', 'description': "Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by Computed Tomography Angiography (CTA) and read by the study's core lab. Modified Miller Index ranges from 0 - 16 (higher values mean higher thrombus burden) and a greater negative change is a better outcome."}, {'measure': 'Rate of Device Related Complications Including Clinical Deterioration, Cardiac Injury, Pulmonary Vascular Injury, Major Bleeding, and Device-related Death Within 48 Hours of the Index Procedure.', 'timeFrame': 'Within 48 hours of the procedure', 'description': 'Rate of device related complications including clinical deterioration, cardiac injury, pulmonary vascular injury, major bleeding, and device-related death within 48 hours of the index procedure.'}, {'measure': 'Rate of Device-related Serious Adverse Events (SAEs) and Death for Any Cause Within 30 Days Post-procedure.', 'timeFrame': 'Within 30 days of the procedure', 'description': 'Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post-procedure.'}, {'measure': 'Symptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days.', 'timeFrame': 'Within 30 days of the procedure', 'description': 'Symptomatic PE recurrence within 30 days.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pulmonary Embolism', 'Acute Pulmonary Embolism']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and effectiveness of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed and dated informed consent form.\n* 18 years of age and older.\n* Clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days.\n* Diagnosis of pulmonary embolism detected from computed tomography angiography (CTA).\n* Right Ventricle to Left Ventricle (RV/LV) ratio of 0.9 or higher.\n* Systolic blood pressure (SBP) of 90 mmHg or higher\n* Heart rate of 130 beats per minute (BPM) or less prior to the procedure.\n* Deemed medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment.\n\nExclusion Criteria:\n\nExcluded from the study if he/she meets any of the following exclusion criteria\n\n* May be pregnant as determined by a positive pregnancy test or who are breastfeeding.\n* Has any contraindication to systemic or therapeutic doses of heparin or anticoagulants.\n* Has used thrombolytics (tPA) in the past 30 days of baseline CTA.\n* Has pulmonary hypertension with peak pulmonary artery pressure (PAP) \\> 70 mmHg.\n* Fraction of inspired oxygen (FiO2) requirement \\>40% or \\>6 liters per minute (LPM) to keep oxygen saturations \\>90%\n* Hematocrit \\<28% within 6 hours of the index procedure.\n* Platelets count \\< 100,000/µL.\n* Serum creatinine \\>1.8 mg/dL.\n* International Normalized Ratio (INR) \\> 3\n* Has undergone a major trauma within the past 14 days of the index procedure and have Injury Severity Score (ISS) \\> 15.\n* Presence of cancer requiring active chemotherapy.\n* Known bleeding diathesis or coagulation disorder.\n* Has had a cardiovascular or pulmonary surgery within the past 7 days of index procedure.\n* History of severe or chronic pulmonary hypertension, uncompensated heart failure, chest irradiation, underlying lung disease that is oxygen dependent, Heparin-induced thrombocytopenia (HIT) and/or chronic left heart disease with left ventricular ejection fraction ≤ 30%.\n* Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated.\n* Requires Vasopressor after fluids to keep pressure ≥ 90 mmHg.\n* With left bundle branch block.\n* Has intracardiac lead in the right ventricle or atrium.\n* Evidence such as imaging or other that suggests the subject is not appropriate for this procedure.\n* Has life expectancy \\< 90 days.\n* Dependent on extracorporeal life support such as extracorporeal membrane oxygenation (ECMO).\n* Participation in another investigational study'}, 'identificationModule': {'nctId': 'NCT05318092', 'acronym': 'APEX-AV', 'briefTitle': 'Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism', 'organization': {'class': 'INDUSTRY', 'fullName': 'Angiodynamics, Inc.'}, 'officialTitle': 'Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism', 'orgStudyIdInfo': {'id': '2021-EVT-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE', 'description': "Single Arm Study - Use of AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for the treatment of acute pulmonary embolism", 'interventionNames': ['Device: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE']}], 'interventions': [{'name': 'AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE', 'type': 'DEVICE', 'description': "The AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE has five main components, a flexible cannula (F1885), sheath, tapered obturator, aspirator handle, and waste bag.", 'armGroupLabels': ['AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'HonorHealth', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90404', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Health', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '06519', 'city': 'New Haven', 'state': 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