Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-29 @ 6:42 AM
Study NCT ID:
NCT05112250
Status:
COMPLETED
Last Update Posted:
2021-11-08
First Post:
2021-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IVL for Stent Underexpantsion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-05', 'studyFirstSubmitDate': '2021-10-19', 'studyFirstSubmitQcDate': '2021-11-05', 'lastUpdatePostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Success', 'timeFrame': '30 days', 'description': 'Reduction of stent underexpansion to the value of \\<30% with no evidence of in-hospital device-oriented composite end point (DOCE)'}], 'secondaryOutcomes': [{'measure': 'DOCE', 'timeFrame': '30 days', 'description': 'composite of cardiac death, target lesion revascularization (TLR), target lesion revascularization, (TLR), and target vessel myocardial infarction (MI)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['In Stent Restenosis', 'Coronary Artery Calcification', 'Intravascular Lithotripsy']}, 'descriptionModule': {'briefSummary': 'The IVL-Dragon Registry was a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL in high-volume PCI centers. The primary efficacy endpoint was clinical success, defined as a reduction of stent underexpansion to \\<30% with no evidence of in-hospital device-oriented composite end point (DOCE) (defined as a composite of cardiac death, target lesion revascularization, and target vessel myocardial infarction).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'consecutive patients with stent underexpansion treated with intravascular lithotripsy (IVL)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stent underexpansion treated with intravascular lithotripsy (IVL)\n\nExclusion Criteria:\n\n* no'}, 'identificationModule': {'nctId': 'NCT05112250', 'acronym': 'IVL-DRAGON', 'briefTitle': 'IVL for Stent Underexpantsion', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Silesia'}, 'officialTitle': 'Intravascular Lithotripsy for the Treatment of Stent Underexpansion: the Multicenter IVL-DRAGON Registry', 'orgStudyIdInfo': {'id': '06'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Percutaneous Coronary Intervention', 'type': 'DEVICE', 'description': 'Intravascular lithotripsy (IVL)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bialystok', 'country': 'Poland', 'facility': 'Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Gdansk', 'country': 'Poland', 'facility': 'First Department of Cardiology, Medical University of Gdansk', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '40-635', 'city': 'Katowice', 'country': 'Poland', 'facility': 'Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Lubin', 'country': 'Poland', 'facility': 'Miedziowe Centrum Zdrowia S.A.', 'geoPoint': {'lat': 51.40089, 'lon': 16.20149}}, {'city': 'Opole', 'country': 'Poland', 'facility': 'Department of Cardiology, University Hospital, Institute of Medical Sciences', 'geoPoint': {'lat': 50.67119, 'lon': 17.92604}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Department of Cardiology, Poznan University of Medical Sciences', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Department of Cardiology', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Rzeszów', 'country': 'Poland', 'facility': 'Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': '1st Department of Cardiology, Medical University of Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Department of Cardiology and Internal Diseases, Military Institute of Medicine', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Wejherowo', 'country': 'Poland', 'facility': 'Department of Invasive Cardiology, Wejherowo', 'geoPoint': {'lat': 54.60568, 'lon': 18.23559}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Zabrze', 'country': 'Poland', 'facility': 'Third Department of Cardiology, Medical University of Katowice', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Silesia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wojciech Wojakowski', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Wojciech Wańha', 'investigatorAffiliation': 'Medical University of Silesia'}}}}