Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT01673893
Status:
COMPLETED
Last Update Posted:
2018-11-29
First Post:
2012-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
ClearWay Rx Readmission Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D000072658', 'term': 'Non-ST Elevated Myocardial Infarction'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'deanna.benoit@cardio.com', 'phone': '985-876-0300', 'title': 'Deanna K. Benoit, LPN, CCRC', 'phoneExt': '5613', 'organization': 'Cardiovascular Institute of the South Clinical Research Corporation'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Serious, and Other \\[Not Including Serious\\] Adverse Events were not monitored/assessed on 7 participants with re-admissions within 30 days post pci and 3 participants who had Cardiovascular Admissions within 30-days that were not preplanned or elective. Re-admissions were captured for data purposes only, not followed.', 'eventGroups': [{'id': 'EG000', 'description': 'Serious, and Other \\[Not Including Serious\\] Adverse Events were not monitored/assessed on 7 participants with re-admissions within 30 days post pci and 3 participants who had Cardiovascular Admissions within 30-days that were not preplanned or elective. Re-admissions were captured for data purposes only, not followed.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '30 Day Readmissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'No. Re-admission Within 30-days Post Pci', 'description': 'No. of Re-admission within 30-days post pci'}, {'id': 'OG001', 'title': 'No. of Cardiovascular Admissions Within 30-days', 'description': 'No. of Cardiovascular Admissions within 30-days: not preplanned, not elective'}, {'id': 'OG002', 'title': 'No. of Patients Compliant With DAPT', 'description': 'No. of patients compliant with Dual Anti Platelet Therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 Days', 'description': 'Collecting data for STEMI and NSTEMI patients for 30 day readmissions after the STEMI or NSTEMI with use of the clearway catheter during the procedure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The above documentation shows the number of readmissions within 30days of post PCI with 7 subjects. The number of cardiovascular Admissiosn within 30 days that were not preplanned or elective are 3. The number of subjects compliant with the dual anti platelet therapy consists of 59 subjects who completed the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Readmission Results', 'description': 'The registry will record the use of the ClearWay™ Rx catheter during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure.\n\nClearWay™ Rx catheter'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ST Elevation Myocardial Infarction', 'description': 'The registry will record the use of the ClearWay™ Rx catheter during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure.\n\n1st Group/Cohort - STEMI: ST elevation myocardial infarction'}, {'id': 'BG001', 'title': 'Non ST Elevation Myocardial Infarction/ACS/UNSTABLE ANGINA', 'description': 'The registry will record the use of the ClearWay™ Rx catheter during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure.\n\n2nd Group/Cohort - NSTEMI: Non-ST elevation myocardial infarction/ACS/Unstable Angina'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<50 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': '50 to 65 years', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': '65 to 75 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': '>= 75 Years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'years'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-01', 'studyFirstSubmitDate': '2012-08-24', 'resultsFirstSubmitDate': '2017-01-25', 'studyFirstSubmitQcDate': '2012-08-24', 'lastUpdatePostDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-29', 'studyFirstPostDateStruct': {'date': '2012-08-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30 Day Readmissions', 'timeFrame': '30 Days', 'description': 'Collecting data for STEMI and NSTEMI patients for 30 day readmissions after the STEMI or NSTEMI with use of the clearway catheter during the procedure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ClearWay', 'Glycoprotein', 'Primary Coronary Intervention', 'Abciximab', 'ST Elevation Myocardial Infarction', 'Non-ST Elevation Myocardial Infarction', 'Medicare', 'Medicaid', 'Registry', 'catheterization', 'readmission', 'Acute Coronary Syndrome', 'ClearwayRx Catheter'], 'conditions': ['Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Krumholz, et al. Circulation 2009; 2:407-413.'}, {'type': 'BACKGROUND', 'citation': 'Thiele, et al. Circulation 2008 Vol. 118'}, {'pmid': '17160551', 'type': 'BACKGROUND', 'citation': 'Romagnoli E, Burzotta F, Trani C, Biondi-Zoccai GG, Giannico F, Crea F. Rationale for intracoronary administration of abciximab. J Thromb Thrombolysis. 2007 Feb;23(1):57-63. doi: 10.1007/s11239-006-9000-0.'}, {'type': 'BACKGROUND', 'citation': 'Hassan, et al. American Heart Journal. Volume 154;2:345-351.'}, {'pmid': '19712799', 'type': 'BACKGROUND', 'citation': 'Curtis JP, Schreiner G, Wang Y, Chen J, Spertus JA, Rumsfeld JS, Brindis RG, Krumholz HM. All-cause readmission and repeat revascularization after percutaneous coronary intervention in a cohort of medicare patients. J Am Coll Cardiol. 2009 Sep 1;54(10):903-7. doi: 10.1016/j.jacc.2009.04.076.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this registry is to determine if delivery of weight adjusted, in a large dose with either Abcixmab or Eptifibitide through the ClearWay™ RX, in patients admitted for primary coronary intervention lowers readmission rate. This is done in comparison to the historical control of the Medicare/Medicaid readmission database. The registry will record the use of the product during the index procedure, and determine whether or not the patient was readmitted within 30 days, related to the index procedure.', 'detailedDescription': 'The primary goal of this registry is to prospectively assess if delivery of weight adjusted, bolus only with either abcixmab or eptifibitide through the ClearWay™ RX in patients admitted for primary PCI lowers readmission rate in comparison to the historical control of the Medicare/Medicaid readmission database. The registry will record the use of the product during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure.\n\nThe ClearWay™ RX Local Therapeutic Infusion Catheter is a micro-porous PTFE balloon catheter designed for the localized infusion of various diagnostic and therapeutic agents into the coronary and peripheral vasculature. The ClearWay™ RX creates a low pressure fluid layer that surrounds the balloon, allowing more effective delivery of a prescribed therapeutic agent, without excessive stress and uncontrollable mechanical disruption seen with more traditional elastomeric devices. In addition, the ClearWay™ RX is a low pressure irrigating balloon system and non-compliant balloon that limits the amount of mechanical stress on the vessel wall.\n\nThe objective of this prospective registry is to evaluate whether intracoronary (IC) delivery of Glycoprotein IIb/IIIa inhibitors (GP IIb/IIIa) during Primary Coronary Intervention (PCI) can reduce the likelihood of 30 day readmissions as a result of the original coronary intervention. Intracoronary delivery of GP IIb/IIa inhibitor Abciximab in ST Elevation Myocardial Infarction has shown to reduce myocardial infarct size, no reflow or slow flow, improve TIMI flow and Myocardial Blush Grade2,3. The ICE trial4 (N=376) compared IC delivery of GP IIb/IIa inhibitor Eptifibitide bolus only administration, bolus with maintenance infusion of Eptifibitide, to standard intravenous (IV) bolus with maintenance infusion. At 24 month follow up, the Major Adverse Coronary Events (MACE) rate was lower in the IC bolus only group (2.5%) versus IC bolus and maintenance infusion (5.8%), and IV bolus with maintenance infusion (10.8%). Further, target lesion revascularization, and readmission rates were significantly lower in the IC bolus only arm, (10.9% versus 16.8% and 28% respectively).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients presenting with myocardial infarction', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute Coronary Syndrome (ST elevation myocardial infarction or Non ST elevation myocardial infarction) patients requiring the use of the ClearWay™ Rx local therapeutic infusion catheter for intracoronary delivery of GP IIb/IIIa inhibitor.\n\nExclusion Criteria:\n\n* Patients not meeting the above inclusion criterion'}, 'identificationModule': {'nctId': 'NCT01673893', 'acronym': 'ClearWay', 'briefTitle': 'ClearWay Rx Readmission Registry', 'organization': {'class': 'OTHER', 'fullName': 'Cardiovascular Institute of the South Clinical Research Corporation'}, 'officialTitle': 'ClearWay Rx Readmission Registry', 'orgStudyIdInfo': {'id': 'K061680'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ST elevation myocardial infarction', 'description': 'The registry will record the use of the ClearWay™ Rx catheter during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure.\n\n1st Group/Cohort - ST elevation myocardial infarction', 'interventionNames': ['Device: ClearWay™ Rx catheter']}, {'label': 'Non-ST elevation myocardial infarction/ACS/UNSTABLE ANGINA', 'description': 'The registry will record the use of the ClearWay™ Rx catheter during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure.\n\n2nd Group/Cohort - Non-ST elevation myocardial infarction/ACS/Unstable Angina', 'interventionNames': ['Device: ClearWay™ Rx catheter']}], 'interventions': [{'name': 'ClearWay™ Rx catheter', 'type': 'DEVICE', 'armGroupLabels': ['Non-ST elevation myocardial infarction/ACS/UNSTABLE ANGINA', 'ST elevation myocardial infarction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70503', 'city': 'Lafayette', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Cardiovascular Institute of the South Clinical Research Corporation', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}], 'overallOfficials': [{'name': 'Nick Cavros, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiovascular Institute of the South'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiovascular Institute of the South Clinical Research Corporation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}