Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2026-01-02 @ 3:06 AM
Study NCT ID:
NCT00534859
Status:
COMPLETED
Last Update Posted:
2011-03-21
First Post:
2007-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-18', 'studyFirstSubmitDate': '2007-09-24', 'studyFirstSubmitQcDate': '2007-09-24', 'lastUpdatePostDateStruct': {'date': '2011-03-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACCE Events at 30 days or discharge, whichever is longer', 'timeFrame': '30 days or discharge', 'description': 'Major Adverse Cardiac and Cerebral (MACCE) events defined as death, new myocardial infarction, target vessel revascularization, urgent coronary artery bypass grafting procedure or cerebral vascular accident during and up to 30 days post-device explant or hospital discharge, whichever is longer.'}, {'measure': 'Freedom from Hemodynamic compromise during PCI procedure', 'timeFrame': 'During procedure', 'description': 'Freedom from Hemodynamic compromise during PCI procedure defined as: Mean Arterial Pressure (MAP) not falling below 60mm Hg for more than 10 minutes during the PCI procedure and additional pressor medication is not required'}], 'secondaryOutcomes': [{'measure': 'Other intra-procedural and peri-procedural adverse events', 'timeFrame': 'During treatment and out to 90 days'}, {'measure': 'Freedom from Ventricular fibrillation and Tachycardia requiring electrical cardioversion', 'timeFrame': 'During procedure', 'description': 'Freedom from the following procedural-related events:\n\ni. Ventricular fibrillation ii. Tachycardia requiring electrical cardioversion'}, {'measure': 'Angiographic Success', 'timeFrame': 'Post-PCI', 'description': 'Angiographic success defined as residual stenosis \\<30% after stent implantation or \\<50% after balloon angioplasty.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Patients Undergoing High Risk PCI.']}, 'referencesModule': {'references': [{'pmid': '19463408', 'type': 'DERIVED', 'citation': "Dixon SR, Henriques JP, Mauri L, Sjauw K, Civitello A, Kar B, Loyalka P, Resnic FS, Teirstein P, Makkar R, Palacios IF, Collins M, Moses J, Benali K, O'Neill WW. A prospective feasibility trial investigating the use of the Impella 2.5 system in patients undergoing high-risk percutaneous coronary intervention (The PROTECT I Trial): initial U.S. experience. JACC Cardiovasc Interv. 2009 Feb;2(2):91-6. doi: 10.1016/j.jcin.2008.11.005."}]}, 'descriptionModule': {'briefSummary': 'The objective of this feasibility study is to demonstrate that the device is safe and potentially efficacious for use in patients undergoing high risk Percutaneous Coronary Interventions(PCI).Patients will be enrolled if they meet inclusion \\& exclusion criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed Informed Consent\n* Non emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft\n* EF \\<35%\n\nExclusion Criteria:\n\n* ST Myocardial Infarction\n* Cardiac Arrest\n* Cardiogenic Shock\n* Thrombus Left Ventricle'}, 'identificationModule': {'nctId': 'NCT00534859', 'acronym': 'PROTECT I', 'briefTitle': 'PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abiomed Inc.'}, 'officialTitle': 'PROTECT I, A Prospective Feasibility Trial Investigating the Use of the IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI', 'orgStudyIdInfo': {'id': 'G050017'}}, 'armsInterventionsModule': {'interventions': [{'name': 'High Risk PCI', 'type': 'DEVICE', 'description': 'High Risk Percutaneous Coronary Intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Mass General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Brigham & Womens', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '10029-6574', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mt. Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Presbyterian Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '777030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Heart', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Amsterdam', 'state': 'Netherland', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': "William O'Neill, M.D.", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Not affiliated with Abiomed'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abiomed Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Carol Pekar/Director of Clinical and Regulatory Affairs', 'oldOrganization': 'Abiomed Inc'}}}}