Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT05656118
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-08
First Post:
2022-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Paclitax Coated Balloon in Patients With Coronary In-stent Restenosis (ISR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-03', 'studyFirstSubmitDate': '2022-12-11', 'studyFirstSubmitQcDate': '2022-12-11', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Targeted lesion failure', 'timeFrame': '12 months', 'description': 'A composite of cardiac death, target-vessel MI, or target lesion revascularization'}], 'secondaryOutcomes': [{'measure': 'Major adverse cardiovascular events', 'timeFrame': '12 months', 'description': 'A composite of all-cause death, MI, or revascularization'}, {'measure': 'All-cause death', 'timeFrame': '12 months', 'description': 'All-cause death and cardiac death'}, {'measure': 'Any MI', 'timeFrame': '12 months', 'description': 'Any MI and target vessel MI'}, {'measure': 'Any revascularization', 'timeFrame': '12 months', 'description': 'Any revascularization and ischemic driven target lesion revascularization'}, {'measure': 'Major bleeding events, BARC 3, 5', 'timeFrame': '12 months', 'description': 'A composite rate of major bleeding events, BARC 3, 5'}, {'measure': 'Any Stroke', 'timeFrame': '12 months', 'description': 'Ischemic or hemorrhagic stroke'}, {'measure': 'Any stent thrombosis', 'timeFrame': '12 months', 'description': 'Definite or probable stent thrombosis (acute, subacute, late)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['In-stent Restenosis', 'Drug-coated balloon'], 'conditions': ['In-stent Restenosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study was to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter in coronary in-stent restenosis (ISR) patients.\n\nThe primary endpoint was target lesion failure (TLF, a composite of cardiac death, target-vessel MI, or target lesion revascularization) at 12 months.', 'detailedDescription': "260 subjects treated with a paclitaxel-coated balloon (Genoss® DCB) in patients with coronary in-stent restenosis (ISR) will be recruited and followed up to 12 months.\n\nAll enrolled patients treated with Genoss DCB in patients with coronary in-stent restenosis (ISR) will be included in the analysis unless there is a valid reason or rationale for it, and the final statistical analysis will follow the intention-to-treat (ITT) principle as assigned. Standard descriptive statistics will be used for patient baseline characteristics, lesions, procedures, and clinical event outcomes. Categorical variables will be presented as percentages and numbers and compared using chi-square or Fisher's exact test. Continuous variables will appear as mean, standard deviation or median, and interquartile range, and will be compared with Student's T-test or Wilcoxon rank sum test, and the normal value of the standard variable distribution will be predicted through histogram, skewness, kurtosis, and Kolmogorov Smirnov one sample test."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects treated with a paclitaxel-coated balloon (Genoss® DCB) in patients with coronary in-stent restenosis (ISR)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n① Age ≥18 years old.\n\n② Patients treated with Genoss® DCB in coronary artery In-stent restenosis (ISR) patients.\n\n③ Patients who can understand the purpose of the study and voluntarily participate in and sign informed consent.\n\nExclusion Criteria:\n\n* A woman who is pregnant, lactating, or planning a pregnancy. ② Patients who are scheduled for surgery requiring discontinuation of antiplatelet drugs within 12 months.\n\n * Patients with life expectancy less than 1 year.\n\n * Patients with cardiogenic shock and are predicted to have a low survival rate based on medical judgment.\n\n * Patients participating in a medical device randomized controlled trials. ⑥ Patients who, in the judgment of the investigator, are not suitable for this clinical study or may increase the risks associated with participation in the study.'}, 'identificationModule': {'nctId': 'NCT05656118', 'acronym': 'GENISPIRE', 'briefTitle': 'Safety and Efficacy of Paclitax Coated Balloon in Patients With Coronary In-stent Restenosis (ISR)', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Safety and Efficacy of Paclitax Drug Coated Balloon Catheter (Genoss® DCB) in Patients With Coronary In-stent Restenosis (ISR): A Prospective, Multi-center, Observational Study (GENISPIRE Registry)', 'orgStudyIdInfo': {'id': '9-2022-0063'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Paclitaxel Coated Balloon', 'description': 'Patients treated with Genoss® DCB in patients with coronary artery in-stent restenosis (ISR)', 'interventionNames': ['Device: Genoss® DCB']}], 'interventions': [{'name': 'Genoss® DCB', 'type': 'DEVICE', 'description': 'Paclitaxel coated balloon with a shellac plus vitamin E excipient', 'armGroupLabels': ['Paclitaxel Coated Balloon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49267', 'city': 'Busan', 'state': 'Busan', 'country': 'South Korea', 'facility': 'Kosin University Gospel Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '24289', 'city': 'Chuncheon', 'state': 'Gangwon-do', 'country': 'South Korea', 'facility': 'Kangwon National University Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'zip': '15355', 'city': 'Ansan-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 37.32361, 'lon': 126.82194}}, {'zip': '10380', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Inje University Ilsan Paik Hospital', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '10444', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'National Health Insurance Service Ilsan Hospital', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '16995', 'city': 'Yongin-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Yongin Severance Hospital, Yonsei University', 'geoPoint': {'lat': 37.29686, 'lon': 127.08042}}, {'zip': '136-705', 'city': 'Daegu', 'state': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': 'Kyungpook National University College Hospital'}, {'zip': '50612', 'city': 'Yangsan', 'state': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}, {'zip': '54907', 'city': 'Jeonju', 'state': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Jeonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'zip': '02841', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University ANAM Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Deok-Kyu Cho, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yongin Severance Hospital, Yonsei University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data set is available from the the corresponding author upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Department of Cardiology, Yongin Severance Hospital, Yonsei University College of Medicine', 'investigatorFullName': 'Deok-Kyu Cho', 'investigatorAffiliation': 'Yonsei University'}}}}