Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT05077657
Status:
COMPLETED
Last Update Posted:
2024-02-16
First Post:
2021-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2021-10-01', 'studyFirstSubmitQcDate': '2021-10-01', 'lastUpdatePostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Access site related bleeding complications', 'timeFrame': 'Within 24 hours', 'description': 'Safety Endpoint'}, {'measure': 'Access site related vascular complications', 'timeFrame': 'Within 24 hours', 'description': 'Safety Endpoint'}, {'measure': 'Access site related blood transfusions', 'timeFrame': 'Within 24 hours', 'description': 'Safety Endpoint'}, {'measure': 'Non-access site related bleeding complications', 'timeFrame': 'Within 24 hours', 'description': 'Safety Endpoint'}, {'measure': 'Non-access site related vascular complications', 'timeFrame': 'Within 24 hours', 'description': 'Safety Endpoint'}, {'measure': 'Non-access site related blood transfusions', 'timeFrame': 'Within 24 hours', 'description': 'Safety Endpoint'}, {'measure': 'All blood transfusions', 'timeFrame': 'Within 24 hours', 'description': 'Safety Endpoint'}, {'measure': 'Hemoglobin drop', 'timeFrame': 'Within 24 hours', 'description': 'Safety Endpoint'}, {'measure': 'Death', 'timeFrame': 'Within 24 hours', 'description': 'Safety Endpoint'}, {'measure': 'Device and procedure-related adverse events', 'timeFrame': 'Within 24 hours', 'description': 'Safety Endpoint'}, {'measure': 'Serious adverse events', 'timeFrame': 'Within 24 hours', 'description': 'Safety Endpoint'}, {'measure': 'Serious adverse device effects', 'timeFrame': 'Within 24 hours', 'description': 'Safety Endpoint'}], 'primaryOutcomes': [{'measure': 'Incidence of access site related BARC type III or V bleeding', 'timeFrame': 'Within 24 hours'}], 'secondaryOutcomes': [{'measure': 'Incidence of activation of each Saranas Early Bird level 1, 2 and 3 indicator', 'timeFrame': 'Within 24 hours'}, {'measure': 'Incidence of all BARC type III or V bleeding', 'timeFrame': 'Within 24 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Percutaneous Coronary Intervention'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to establish the safety of complex high-risk Percutaneous Coronary Intervention (PCI) using Mechanical Circulatory Support (MCS) and surveillance with the Saranas Early Bird Bleed Monitoring System (EBBMS).', 'detailedDescription': 'To demonstrate that patients undergoing complex high-risk PCI using MCS and surveillance with the Saranas Early Bird Bleed Monitoring System will have relative incidence rate reduction of access site related BARC type III or V bleeding. An optimal outcome will show a a reduction in access-site related bleeding rate when using MCS with the Saranas EBBMS in high-risk PCI patients compared to historical incidence rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing complex high-risk percutaneous coronary intervention (PCI) with mechanical circulatory support (MCS) via Impella® and transfemoral arterial approach will be enrolled. The Saranas Early Bird Bleed Monitoring System will be used in the ipsilateral femoral vein to monitor bleeding events after MCS removal.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years of age\n* Planned complex high-risk PCI using MCS with Impella from a femoral access and use of Saranas Early Bird Bleed Monitoring System\n* The study patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the institutional review board of the respective clinical site.\n\nExclusion Criteria:\n\n* Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication\n* Active bleeding\n* Incapacity to access safely femoral artery or femoral vein\n* Significant femoral, iliac, abdominal, or thoracic aortic disease which precludes placement of MCS\n* Anemia (Hgb \\<9 g/dL), thrombocytopenia (Plt \\<50,000 cell/mL), history of bleeding diathesis or coagulopathy, or hypercoagulable states\n* Active infection not controlled with antibiotic therapy\n* Currently pregnant or women of child-bearing potential without documented negative pregnancy test\n* Estimated life expectancy \\< 24 hours\n* Patient is in cardiogenic shock at the time of enrollment'}, 'identificationModule': {'nctId': 'NCT05077657', 'acronym': 'SAFE-MCS', 'briefTitle': 'Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Saranas, Inc.'}, 'officialTitle': 'Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System', 'orgStudyIdInfo': {'id': 'PVP012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single-Arm', 'description': 'This is a multi-center, single arm, open-label study to evaluate the safety of complex high-risk PCI using Impella and surveillance with the Saranas Early Bird Bleed Monitoring System (EBBMS).', 'interventionNames': ['Device: Early Bird® Bleed Monitoring System', 'Device: Impella®']}], 'interventions': [{'name': 'Early Bird® Bleed Monitoring System', 'type': 'DEVICE', 'description': 'The Early Bird Bleed Monitoring System is used in endovascular procedures to monitor and detect internal bleeding complications in real-time.', 'armGroupLabels': ['Single-Arm']}, {'name': 'Impella®', 'type': 'DEVICE', 'description': 'Impella is an FDA-approved percutaneous heart pump indicated for patients with severe coronary artery disease requiring high-risk PCI.', 'armGroupLabels': ['Single-Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'St. Joseph Hospital / Arizona Heart', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tucson Medical Center / PIMA Heart', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '46402', 'city': 'Gary', 'state': 'Indiana', 'country': 'United States', 'facility': 'Methodist Hospitals', 'geoPoint': {'lat': 41.59337, 'lon': -87.34643}}, {'zip': '48124', 'city': 'Dearborn', 'state': 'Michigan', 'country': 'United States', 'facility': 'Ascension - St. John', 'geoPoint': {'lat': 42.32226, 'lon': -83.17631}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '08837', 'city': 'Edison', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack Meridian Health', 'geoPoint': {'lat': 40.51872, 'lon': -74.4121}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Morristown Medical Center', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '11042', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell / Lenox Hill & Staten Island', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Hermann / UTH', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "St. Luke's / Texas Heart", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77021', 'city': 'Kingwood', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Hermann NE / TCR Institute', 'geoPoint': {'lat': 30.05691, 'lon': -95.18349}}], 'overallOfficials': [{'name': 'Mir Basir, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henry Ford Hospital'}, {'name': 'Philippe Généreux, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gagnon Cardiovascular Institute - Morristown Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saranas, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Proxima CRO', 'class': 'INDUSTRY'}, {'name': 'Cardiovascular Research Foundation, New York', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}