Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-02-25 @ 6:35 PM
Study NCT ID:
NCT01787604
Status:
COMPLETED
Last Update Posted:
2019-06-10
First Post:
2013-01-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Aortic Root Reimplantation Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001022', 'term': 'Aortic Valve Insufficiency'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dmhvan@mail.ru', 'phone': '+79069090505', 'title': 'Dmitry', 'organization': 'MeshalkinRI'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 4 yeras', 'eventGroups': [{'id': 'EG000', 'title': 'Aortic Root Reimplantation Procedure', 'description': 'Aortic Root Reimplantation Procedure\n\nAortic Root Reimplantation Procedure: Modified Florida Sleeve.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Aortic Valve Reimplantation Procedure', 'description': 'Aortic Valve Reimplantation Procedure\n\nAortic Valve Reimplantation Procedure: David I', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 4, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aortic Root Reimplantation Procedure', 'description': 'Aortic Root Reimplantation Procedure\n\nAortic Root Reimplantation Procedure: Modified Florida Sleeve.'}, {'id': 'OG001', 'title': 'Aortic Valve Reimplantation Procedure', 'description': 'Aortic Valve Reimplantation Procedure\n\nAortic Valve Reimplantation Procedure: David I'}], 'classes': [{'categories': [{'measurements': [{'value': '88.2', 'groupId': 'OG000'}, {'value': '87.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 4 yeras', 'description': 'Estimated percentage of participants free from aortic insufficiency (AI) more than 2+ measured by echocardiography for a 4 years after treatment..', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Survival (Percentage, Kaplan-Meier)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aortic Root Reimplantation Procedure', 'description': 'Aortic Root Reimplantation Procedure\n\nAortic Root Reimplantation Procedure: Modified Florida Sleeve.'}, {'id': 'OG001', 'title': 'Aortic Valve Reimplantation Procedure', 'description': 'Aortic Valve Reimplantation Procedure\n\nAortic Valve Reimplantation Procedure: David I'}], 'classes': [{'categories': [{'measurements': [{'value': '82.7', 'groupId': 'OG000'}, {'value': '84.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 4 yeras', 'description': 'Estimated percentage of alive participants for 4 years after treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aortic Root Reimplantation Procedure', 'description': 'Aortic Root Reimplantation Procedure\n\nAortic Root Reimplantation Procedure: Modified Florida Sleeve.'}, {'id': 'FG001', 'title': 'Aortic Valve Reimplantation Procedure', 'description': 'Aortic Valve Reimplantation Procedure\n\nAortic Valve Reimplantation Procedure: David I'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aortic Root Reimplantation Procedure', 'description': 'Aortic Root Reimplantation Procedure\n\nAortic Root Reimplantation Procedure: Modified Florida Sleeve.'}, {'id': 'BG001', 'title': 'Aortic Valve Reimplantation Procedure', 'description': 'Aortic Valve Reimplantation Procedure\n\nAortic Valve Reimplantation Procedure: David I'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '52', 'upperLimit': '65'}, {'value': '56', 'groupId': 'BG001', 'lowerLimit': '50', 'upperLimit': '63'}, {'value': '58', 'groupId': 'BG002', 'lowerLimit': '52', 'upperLimit': '64'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2015-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-10', 'studyFirstSubmitDate': '2013-01-30', 'resultsFirstSubmitDate': '2017-09-07', 'studyFirstSubmitQcDate': '2013-02-06', 'lastUpdatePostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-10', 'studyFirstPostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier)', 'timeFrame': 'up to 4 yeras', 'description': 'Estimated percentage of participants free from aortic insufficiency (AI) more than 2+ measured by echocardiography for a 4 years after treatment..'}], 'secondaryOutcomes': [{'measure': 'Survival (Percentage, Kaplan-Meier)', 'timeFrame': 'up to 4 yeras', 'description': 'Estimated percentage of alive participants for 4 years after treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Valve-sparing', 'Valve repair'], 'conditions': ['Ascending Aortic Aneurism', 'Aortic Valve Insufficiency']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Alexander Chernyavskiy, Sergey Alsov, Dmitry Khvan, Dmitry Sirota. Extravalvular exoprosthetic repair of aortic root: first experience. Kardiochirurgia i Torakochirurgia Polska 2012; 9 (4): 409-414 DOI: 10.5114/kitp.2012.32675'}, {'type': 'RESULT', 'citation': 'Чернявский А. М., Хван Д. С., Альсов С. А., Сирота Д. А., Ляшенко М. М. Результаты реимплантации корня аорты в протез у пациентов с аневризмой восходящего отдела аорты и недостаточностью аортального клапана. Патология кровообращения и кардиохирургия. 2015;19(4):38-47. http://dx.doi.org/10.21688/1681-3472-2015-4-38-47'}]}, 'descriptionModule': {'briefSummary': 'Authors hypothesize that aortic root reimplantation procedure is superior over standard aortic valve reimplantation procedure in the incidence of aortic valve replacement.', 'detailedDescription': "A single blind prospective randomized superiority study is conducted. Our hypothesis is that there is difference in the incidence of aortic valve replacement between the standard aortic valve reimplantation procedure and aortic root reimplantation procedure more than 21.1%. If there is truly difference between groups (Aortic Root Reimplantation Procedure and Aortic Valve Reimplantation Procedure), then total 64 patients for both groups are required to be 80% sure that the upper limit of a one-sided 95% confidence interval would reveal a difference in favour of the Aortic Root Reimplantation Procedure of 21.1%. The blinding process is applied to a patient, who is informed about received valve-sparing operation, but don't know the type of the last. The study was approved by Institutional Review Board. Depending on a type of the procedure, the patients are divided into two groups: Aortic Root Reimplantation Procedure group includes 32 patients and Aortic Valve Reimplantation Procedure group consists of 32 patients. Randomization is conducted intraoperatively by using accidental sampling after examining the aortic valve and making a decision on the possibility of a valve-sparing operation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aortic insufficiency 2+\n* Ascending aorta or aortic root of greater than 4.5 cm (\\> 4.0 cm in Marfan syndrome)\n* Good conditions of aortic cusps\n\nExclusion Criteria:\n\n* Aortic annulus more than 32 mm\n* Aortic cusps destruction\n* Critical aortic cusps elongation\n* Aortic root dissection'}, 'identificationModule': {'nctId': 'NCT01787604', 'acronym': 'STAR', 'briefTitle': 'Study of Aortic Root Reimplantation Procedure', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'officialTitle': 'Superiority Trial of Aortic Root Reimplantation Procedure Versus Aortic Valve Reimplantation Procedure', 'orgStudyIdInfo': {'id': 'STAR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aortic Root Reimplantation Procedure', 'description': 'Aortic Root Reimplantation Procedure', 'interventionNames': ['Procedure: Aortic Root Reimplantation Procedure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aortic Valve Reimplantation Procedure', 'description': 'Aortic Valve Reimplantation Procedure', 'interventionNames': ['Procedure: Aortic Valve Reimplantation Procedure']}], 'interventions': [{'name': 'Aortic Root Reimplantation Procedure', 'type': 'PROCEDURE', 'otherNames': ['Modified Florida Sleeve.'], 'description': 'Modified Florida Sleeve.', 'armGroupLabels': ['Aortic Root Reimplantation Procedure']}, {'name': 'Aortic Valve Reimplantation Procedure', 'type': 'PROCEDURE', 'otherNames': ['David I'], 'description': 'David I', 'armGroupLabels': ['Aortic Valve Reimplantation Procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '630055', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Meshalkin State Research Institute of Circulation Pathology', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'cardiac surgeon', 'investigatorFullName': 'Dmitry Khvan', 'investigatorAffiliation': 'Meshalkin Research Institute of Pathology of Circulation'}}}}