Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-01-02 @ 2:50 AM
Study NCT ID:
NCT06132568
Status:
COMPLETED
Last Update Posted:
2025-06-22
First Post:
2023-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2023-11-07', 'studyFirstSubmitQcDate': '2023-11-09', 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Success', 'timeFrame': 'Measured through 72 hours or hospital discharge (whichever comes first) after the intervention/procedure', 'description': 'The primary endpoint consists of the composite endpoint of Clinical Success \\[measured through 72 hours or hospital discharge (whichever comes first)\\], which is defined as follows.\n\n* Technical Success: Successful delivery of the device to the correct anatomical position; and Successful operation and removal of the VITALYST circulatory support system\n* Absence of termination of revascularization procedure due to hemodynamic concern, or escalation to ECMO or other more intensive mechanical circulatory support device, or the use of vasopressors or inotropes\n* No conversion to open heart surgery\n* No mortality'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['High-risk Percutaneous Coronary Intervention', 'Heart Disease, Coronary']}, 'descriptionModule': {'briefSummary': 'The VITALYST Early Feasibility study (EFS) is designed to evaluate the feasibility and safety of the VITALYST System in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI).', 'detailedDescription': 'The VITALYST EFS is a prospective, open-label, single-arm, multicenter feasibility study of the VITALYST System.\n\nThe VITALYST System will be used to provide temporary circulatory support in patients undergoing non-emergent high risk percutaneous interventions (HR-PCI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject provides signed informed consent.\n* Subject is ≥ 18 years and \\< 90 years of age.\n* Subject is indicated for NON-emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or coronary artery bypass graft (CABG) and has left ventricular ejection fraction (LVEF) ≤ 50% with the following: Unprotected left main or Last remaining vessel or Three vessel disease (at least one ≥ 50% diameter stenosis based on center's visual assessment in all three major epicardial territories)\n* Heart team, which must include a cardiac surgeon, agrees that HR-PCI is appropriate.\n\nExclusion Criteria:\n\n* Subject has had STEMI within 72 hours with persistent elevation of cardiac enzymes.\n* Subject has had pre-procedure cardiac arrest requiring CPR within 24 hours of enrollment.\n* Subject has systolic blood pressure \\< 90 mmHg with evidence of end organ hypoperfusion (e.g., cool extremities or urine \\< 30 mL/hour).\n* Subject has had need for inotropes/vasopressors or mechanical circulatory support (including intra-aortic balloon pump) in the previous 24 hours to maintain a systolic blood pressure ≥ 90 mmHg.\n* Subject has left ventricular mural thrombus.\n* Subject has a prosthetic aortic valve.\n* Subject has pericarditis or constrictive heart disease (constrictive pericarditis or restrictive cardiomyopathy).\n* Subject has moderate or greater aortic valve stenosis or moderate or greater aortic valve insufficiency (by echocardiographic assessment, graded as \\> 2+).\n* Subject has abnormalities of the aorta that preclude safe delivery of the device, including severe calcification, tortuosity, aneurysm, or prior surgery.\n* Subject has PVD preventing passage of the device (e.g., calcification, small caliber) or tortuosity that would preclude safe placement of the introducer sheath as per the IFU.\n* Subject is not on dialysis and has creatinine \\> 4 mg/dL.\n* Subject has a history of liver dysfunction (Childs Class C) with elevation of liver enzymes and bilirubin \\> 3× ULN or INR ≥ 2.\n* Subject has had a recent (within 30 days) stroke or TIA.\n* Subject has known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or has known hypersensitivity to heparin, aspirin, ADP receptor inhibitors or nitinol.\n* Subject has current or a history of heparin induced thrombocytopenia.\n* Subject has uncorrected abnormal coagulation or platelet count ≤ 75,000/mm³ or INR ≥ 2.0.\n* Subject has significant right heart failure based on any one of the following criteria: RVSWI \\< 0.30 mmHg·L/m² or PVR \\> 3.6 Woods units or Pulmonary artery pulsatility index \\< 1.85\n* Subject requires non-elective mechanical ventilation.\n* Subject has an atrial or ventricular septal defect (including post-infarct VSD).\n* Subject has left ventricular rupture.\n* Subject has cardiac tamponade.\n* Subject has severe pulmonary disease (FEV1 \\< 1L).\n* Subject has sustained or non-sustained ventricular tachycardia.\n* Subject is breast feeding or is pregnant.\n* Subject has infection of the proposed procedural access site or active systemic infection.\n* Subject has any condition that requires premature discontinuation of recommended antiplatelet and/or anticoagulant therapy before 90 days following the index procedure.\n* Any use of a mechanical circulatory support device within 14 days prior to the index procedure.\n* Staged PCI is planned within 90 days following device removal.\n* Subject is participating in another investigational drug or device study that has not reached its primary endpoint.\n* Subject has other disease condition(s) resulting in the subject being unsuitable for participation in the clinical trial (e.g., advanced malignancy with limited expected survival)\n* Subject has other disease condition(s) which the Investigator has determined may cause non-compliance to the study requirements."}, 'identificationModule': {'nctId': 'NCT06132568', 'acronym': 'VITALYST EFS', 'briefTitle': 'VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'VITALYST EFS: VITALYST Temporary Percutaneous Transvalvular Circulatory Support System Early Feasibility Study', 'orgStudyIdInfo': {'id': 'S2496'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Risk PCI Patients', 'description': 'Patients undergoing non-emergent, high-risk percutaneous coronary interventions', 'interventionNames': ['Device: VITALYST System']}], 'interventions': [{'name': 'VITALYST System', 'type': 'DEVICE', 'otherNames': ['Percutaneous Mechanical Circulatory Support'], 'description': 'The VITALYST System is a temporary ventricular support device indicated for use during high-risk percutaneous coronary interventions (HR-PCI) performed electively in hemodynamically stable subjects with severe coronary artery disease.', 'armGroupLabels': ['High Risk PCI Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Heart Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center/New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '222 42', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Skane University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}