Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
Study NCT ID:
NCT06738108
Status:
COMPLETED
Last Update Posted:
2025-01-09
First Post:
2024-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EKOS in Patients With Pulmonary Embolism (PE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2024-12-13', 'studyFirstSubmitQcDate': '2024-12-13', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in RV/LV diameter ratio', 'timeFrame': 'one month', 'description': 'The change in RV/LV diameter ratio from baseline to first outpatient follow-up as documented on an echocardiogram.'}], 'secondaryOutcomes': [{'measure': 'All-cause 30-day readmission', 'timeFrame': 'one month', 'description': 'All-cause 30-day readmission'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ECOS'], 'conditions': ['Pulmonary Embolism']}, 'descriptionModule': {'briefSummary': 'A retrospective cohort study assessed patients who underwent EKOS intervention following the failure of initial therapeutic anticoagulation for managing acute pulmonary embolism at a tertiary hospital.', 'detailedDescription': 'A retrospective cohort study assessed patients who underwent EKOS intervention following the failure of initial therapeutic anticoagulation for managing acute pulmonary embolism at a tertiary hospital. Patients aged at least 18 years with a diagnosis of submassive or massive acute PE were included. Patients were excluded if they either did not receive EKOS intervention or were presented with stable PE. The primary outcome was the change in RV/LV diameter ratio from baseline to first outpatient follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Submassive PE was defined as having right ventricular (RV) dysfunction: detected via CT scan or echocardiography, with signs such as RV enlargement, RV hypokinesis, or RV/LV ratio \\>0.9 to 1.0), elevated cardiac biomarkers like troponin or BNP, which indicate strain or injury to the heart muscle with a maintained blood pressure (SBP equal to or \\> 90 mm Hg with no signs of shock.\n\nMassive PE was defined as SBP \\<90 mm Hg for at least 15 minutes or require vasopressors to maintain adequate blood pressure with clinical signs of poor perfusion, including altered mental status, cool extremities, low urine output, or sudden loss of heart function due to obstructed blood flow from the pulmonary artery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years diagnosed with massive or submassive acute PE.\n\nExclusion Criteria:\n\n1. Patients presented with stable PE\n2. Patients did not receive EKOS intervention.'}, 'identificationModule': {'nctId': 'NCT06738108', 'briefTitle': 'EKOS in Patients With Pulmonary Embolism (PE)', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Safety and Effectiveness of EKOS in PE Patients', 'orgStudyIdInfo': {'id': 'ECOSII'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ECOS group', 'description': 'ECOS', 'interventionNames': ['Drug: ECOS']}, {'label': 'Control group', 'description': 'IV infusion tpa', 'interventionNames': ['Drug: Control group']}], 'interventions': [{'name': 'ECOS', 'type': 'DRUG', 'description': 'The EkoSonic Endovascular System, developed by EKOS Corporation, is a specialized CDT system that combines ultrasound technology with thrombolytic infusion to treat PE', 'armGroupLabels': ['ECOS group']}, {'name': 'Control group', 'type': 'DRUG', 'otherNames': ['IV alteplase infusion'], 'description': 'Alteplase IV infusion', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Saudi German Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of clinical pharmacy', 'investigatorFullName': 'Asmaa Abdelfattah Elsayed', 'investigatorAffiliation': 'Beni-Suef University'}}}}