Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-27 @ 8:56 PM
Study NCT ID:
NCT01638468
Status:
TERMINATED
Last Update Posted:
2018-12-05
First Post:
2012-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multicenter, Nonrandomized, Prospective Study of Pulmonary Embolism Removal With the AngioJet 6F Ultra System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom']}, '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': 'angela.schutt@bsci.com', 'phone': '763-494-2166', 'title': 'Angela Schutt', 'organization': 'Boston Scientific'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the index procedure through the 3 month follow up visit.', 'eventGroups': [{'id': 'EG000', 'title': 'AngioJet Ultra PE Thrombectomy System', 'description': 'Patients are treated with the AngioJet Ultra PE Thrombectomy System\n\nAngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System', 'otherNumAtRisk': 7, 'otherNumAffected': 1, 'seriousNumAtRisk': 7, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis (bleeding from the nose)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pulmonary Embolism, Re-occurring', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bowel Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Macrohematuria (presence of blood cells in urine)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Right Ventricular (RV) to Left Ventricular (LV) Ratio at 24 - 48 Hours as Measured by Echocardiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AngioJet Ultra PE Thrombectomy System', 'description': 'Patients are treated with the AngioJet Ultra PE Thrombectomy System\n\nAngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.610', 'spread': '0.125', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24-48 hours', 'description': 'The change in the subannular end-diastolic RV/LV ratio at 24-48 hrs following thrombectomy compared to baseline measurements as assessed by an independent core lab analysis. RV and LV values will be measured by echocardiography, a technique utilizing ultrasound waves to assess heart activity.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint'}, {'type': 'SECONDARY', 'title': 'Technical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AngioJet Ultra PE Thrombectomy System', 'description': 'Patients are treated with the AngioJet Ultra PE Thrombectomy System\n\nAngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Index Procedure', 'description': 'Percentage of patients with successful placement and operation of the AngioJet catheter in the pulmonary arteries during the index procedure', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint'}, {'type': 'SECONDARY', 'title': 'Death - All Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AngioJet Ultra PE Thrombectomy System', 'description': 'Patients are treated with the AngioJet Ultra PE Thrombectomy System\n\nAngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Number of participant deaths due to any reason occurring within 3 months of the index procedure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint'}, {'type': 'SECONDARY', 'title': 'Death - Cardiac Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AngioJet Ultra PE Thrombectomy System', 'description': 'Patients are treated with the AngioJet Ultra PE Thrombectomy System\n\nAngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Number of participant deaths due to cardiac causes occurring within 3 months of the index procedure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint'}, {'type': 'SECONDARY', 'title': 'Change in Systolic Pulmonary Arterial Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AngioJet Ultra PE Thrombectomy System', 'description': 'Patients are treated with the AngioJet Ultra PE Thrombectomy System\n\nAngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.3', 'spread': '11.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Post Index Procedure', 'description': 'Change in systolic pulmonary arterial blood pressure at termination of the index procedure as compared to the pre-procedure assessment.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 1 participant was not evaluable.'}, {'type': 'SECONDARY', 'title': 'Pulmonary Systolic Arterial Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AngioJet Ultra PE Thrombectomy System', 'description': 'Patients are treated with the AngioJet Ultra PE Thrombectomy System\n\nAngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System'}], 'classes': [{'categories': [{'measurements': [{'value': '44.2', 'spread': '11.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post Index Procedure', 'description': 'Pulmonary systolic arterial blood pressure at termination of the index procedure.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 1 participants were not evaluable.'}, {'type': 'SECONDARY', 'title': 'Change in Systemic Systolic Arterial Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AngioJet Ultra PE Thrombectomy System', 'description': 'Patients are treated with the AngioJet Ultra PE Thrombectomy System\n\nAngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System'}], 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'spread': '22.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Post Index Procedure', 'description': 'Change in systemic systolic arterial blood pressure at termination of the index procedure as compared to the pre-procedure assessment.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint'}, {'type': 'SECONDARY', 'title': 'Systemic Systolic Arterial Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AngioJet Ultra PE Thrombectomy System', 'description': 'Patients are treated with the AngioJet Ultra PE Thrombectomy System\n\nAngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System'}], 'classes': [{'categories': [{'measurements': [{'value': '136.0', 'spread': '18.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post Index Procedure', 'description': 'Systemic systolic arterial blood pressure at termination of the index procedure.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Change in Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AngioJet Ultra PE Thrombectomy System', 'description': 'Patients are treated with the AngioJet Ultra PE Thrombectomy System\n\nAngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.2', 'spread': '9.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Post Index Procedure', 'description': 'Change in heart rate at termination of the index procedure as compared to the pre-procedure assessment.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 2 participants were not evaluable.'}, {'type': 'SECONDARY', 'title': 'Vasopressor Support', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AngioJet Ultra PE Thrombectomy System', 'description': 'Patients are treated with the AngioJet Ultra PE Thrombectomy System\n\nAngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Index Procedure', 'description': 'Percentage of participants receiving vasopressor support during the index procedure. Vasopressor support are medications administered to prevent the narrowing of blood vessels.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint'}, {'type': 'SECONDARY', 'title': 'Procedure Related Adverse Event Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AngioJet Ultra PE Thrombectomy System', 'description': 'Patients are treated with the AngioJet Ultra PE Thrombectomy System\n\nAngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Number of procedure related adverse events occurring within 3 months of the index procedure', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AngioJet Ultra PE Thrombectomy System', 'description': 'Patients are treated with the AngioJet Ultra PE Thrombectomy System\n\nAngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AngioJet Ultra PE Thrombectomy System', 'description': 'Patients are treated with the AngioJet Ultra PE Thrombectomy System\n\nAngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'spread': '8.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '28.33', 'spread': '4.43', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '170.0', 'spread': '12.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '82.6', 'spread': '19.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Slow Enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-12', 'studyFirstSubmitDate': '2012-07-06', 'resultsFirstSubmitDate': '2016-09-12', 'studyFirstSubmitQcDate': '2012-07-09', 'lastUpdatePostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-09-12', 'studyFirstPostDateStruct': {'date': '2012-07-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Right Ventricular (RV) to Left Ventricular (LV) Ratio at 24 - 48 Hours as Measured by Echocardiography', 'timeFrame': 'Baseline to 24-48 hours', 'description': 'The change in the subannular end-diastolic RV/LV ratio at 24-48 hrs following thrombectomy compared to baseline measurements as assessed by an independent core lab analysis. RV and LV values will be measured by echocardiography, a technique utilizing ultrasound waves to assess heart activity.'}], 'secondaryOutcomes': [{'measure': 'Technical Success', 'timeFrame': 'Index Procedure', 'description': 'Percentage of patients with successful placement and operation of the AngioJet catheter in the pulmonary arteries during the index procedure'}, {'measure': 'Death - All Cause', 'timeFrame': '3 months', 'description': 'Number of participant deaths due to any reason occurring within 3 months of the index procedure.'}, {'measure': 'Death - Cardiac Cause', 'timeFrame': '3 months', 'description': 'Number of participant deaths due to cardiac causes occurring within 3 months of the index procedure.'}, {'measure': 'Change in Systolic Pulmonary Arterial Blood Pressure', 'timeFrame': 'Baseline to Post Index Procedure', 'description': 'Change in systolic pulmonary arterial blood pressure at termination of the index procedure as compared to the pre-procedure assessment.'}, {'measure': 'Pulmonary Systolic Arterial Blood Pressure', 'timeFrame': 'Post Index Procedure', 'description': 'Pulmonary systolic arterial blood pressure at termination of the index procedure.'}, {'measure': 'Change in Systemic Systolic Arterial Blood Pressure', 'timeFrame': 'Baseline to Post Index Procedure', 'description': 'Change in systemic systolic arterial blood pressure at termination of the index procedure as compared to the pre-procedure assessment.'}, {'measure': 'Systemic Systolic Arterial Blood Pressure', 'timeFrame': 'Post Index Procedure', 'description': 'Systemic systolic arterial blood pressure at termination of the index procedure.'}, {'measure': 'Change in Heart Rate', 'timeFrame': 'Baseline to Post Index Procedure', 'description': 'Change in heart rate at termination of the index procedure as compared to the pre-procedure assessment.'}, {'measure': 'Vasopressor Support', 'timeFrame': 'Index Procedure', 'description': 'Percentage of participants receiving vasopressor support during the index procedure. Vasopressor support are medications administered to prevent the narrowing of blood vessels.'}, {'measure': 'Procedure Related Adverse Event Rate', 'timeFrame': '3 months', 'description': 'Number of procedure related adverse events occurring within 3 months of the index procedure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pulmonary Embolism', 'Acute Pulmonary Embolism', 'Sub-massive Pulmonary Embolism', 'Massive Pulmonary Embolism', 'Pulmonary Thromboembolism'], 'conditions': ['Pulmonary Embolism']}, 'descriptionModule': {'briefSummary': 'The purpose of this European Post Market Follow-up Plan is designed to evaluate the safety, efficacy, adverse events and any new information that may surface regarding the use of the AngioJet Ultra PE Thrombectomy Catheter System in patients with thrombus in the main pulmonary and lobar arteries ≥ 6mm in diameter.', 'detailedDescription': 'Despite advances in prophylaxis, diagnostic modalities, and therapeutic options, pulmonary embolism remains a commonly under diagnosed and lethal entity. In the United States approximately 150,000 patients per year are diagnosed with acute pulmonary embolisms. Many additional deaths occur each year in the United States as a result of undiagnosed massive pulmonary embolisms. Taking these patients into account, it is thought that up to 600,000 patients develop a pulmonary embolism annually in this country. In patients with acute pulmonary embolism, the most common cause of early death is right ventricular failure.\n\nIn addition to anticoagulation therapy, several reperfusion therapies are being used to reverse right ventricular failure: systemic thrombolysis, surgical embolectomy, and catheter based therapy. Given the drawbacks of systemic thrombolytic therapy or surgical embolectomy, percutaneous catheter treatment is a reasonable alternative for patients with contraindications to systemic thrombolytic therapy or surgery. Current international consensus guidelines support the use of catheter interventions for selected pulmonary embolism patients at increased risk of adverse clinical outcomes.\n\nThe AngioJet Ultra PE Thrombectomy catheter introduces a pressurized high velocity saline stream through a catheter tip so that the clot within a blood vessel is trapped, broken into small pieces and aspirated from the body.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Symptomatic pulmonary embolism patients \\>18 years\n2. Availability of a baseline contrast-enhanced chest computed tomogram or conventional pulmonary angiogram with evidence of pulmonary embolus in at least one main or lobar pulmonary artery ≥ 6mm in diameter\n3. Availability of a baseline transthoracic echocardiogram with sufficient image quality permitting the measurement of right ventricular (RV) and left ventricular (LV) dimensions in the apical or subcostal four-chamber view\n4. Echocardiographic evidence of right ventricular dilatation with a subannular RV/LV ratio ≥ 0.9 from the apical or subcostal four-chamber view\n5. Appropriate informed consent was obtained from the patient or legal representative\n\nExclusion Criteria:\n\n1. Patient has underwent Cardiopulmonary Resuscitation (CPR) in the last 48 hours\n2. Patient is participating in any other clinical study\n3. Pregnancy, lactation or parturition within the previous 30 days (positive pregnancy test, women of childbearing age must be tested or use a medically accepted method of birth control)\n4. Inability to comply with study Follow-up assessments (e.g. due to geographic)\n5. Previous enrollment in this study'}, 'identificationModule': {'nctId': 'NCT01638468', 'acronym': 'PERFUSE', 'briefTitle': 'Multicenter, Nonrandomized, Prospective Study of Pulmonary Embolism Removal With the AngioJet 6F Ultra System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Pulmonary Embolism Removal With the AngioJet 6F Ultra SystEm (PERFUSE)', 'orgStudyIdInfo': {'id': 'PERFUSE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AngioJet Ultra PE Thrombectomy System', 'description': 'Patients are treated with the AngioJet Ultra PE Thrombectomy System', 'interventionNames': ['Device: AngioJet Ultra PE Thrombectomy System']}], 'interventions': [{'name': 'AngioJet Ultra PE Thrombectomy System', 'type': 'DEVICE', 'otherNames': ['AngioJet'], 'description': 'Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System', 'armGroupLabels': ['AngioJet Ultra PE Thrombectomy System']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Münster', 'country': 'Germany', 'facility': 'Universitätsklinikum Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '16128', 'city': 'Genova', 'country': 'Italy', 'facility': 'EO Ospedali Galliera - Genova', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Universita Federico II di Napoli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Ravenna', 'country': 'Italy', 'facility': 'Ospedale S. Maria Delle Croci', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'zip': '22020', 'city': 'San Fermo della Battaglia', 'country': 'Italy', 'facility': "Ospedale Sant' Anna Di Como", 'geoPoint': {'lat': 45.80868, 'lon': 9.04744}}, {'zip': '4434-502', 'city': 'Vila Nova de Gaia', 'country': 'Portugal', 'facility': 'Centro Hospitalar de Vila Nova de Gaia', 'geoPoint': {'lat': 41.12401, 'lon': -8.61241}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'University Hospital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Nils Kucher, Prof Dr Med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}