protocolSection identificationModule nctId: NCT06276114, orgStudyIdInfo id: 07, briefTitle: IVL vs ELCA for Stent Underexpantsion (IVL-ELCA DRAGON), acronym: DRAGON, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-08-01, primaryCompletionDateStruct date: 2023-10-31, completionDateStruct date: 2023-10-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Medical University of Silesia, class: OTHER, descriptionModule briefSummary: The IVL- ELCA DRAGON Registry is a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL ora ELCA in high-volume PCI centers.The primary efficacy endpoint was device success (technical success with a final stent expansion ≥ 80%). Thirty days device-oriented composite endpoint (DOCE: cardiac death, target lesion revascularization, or target vessel myocardial infarction) was the secondary endpoint., conditionsModule conditions: Coronary Artery Calcification, conditions: Intravascular Lithotripsy, conditions: Excimer Laser-coronary Atherectomy, conditions: Stent Restenosis, conditions: Stent Occlusion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 121, type: ACTUAL, armsInterventionsModule interventions name: Stent Underexpansion, outcomesModule primaryOutcomes measure: The primary efficacy endpoint was device success, secondaryOutcomes measure: Device-oriented composite endpoint (DOCE), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Unit of Structural Interventional Cardiology, Department of Clinical and Experimental Medicine, Careggi University Hospital, city: Florence, country: Italy, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Fabrizio D'Ascenzo, city: Turin, country: Italy, geoPoint lat: 45.07049, lon: 7.68682, locations facility: Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital, city: Białystok, country: Poland, geoPoint lat: 53.13333, lon: 23.16433, locations facility: First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland, city: Gdańsk, country: Poland, geoPoint lat: 54.35205, lon: 18.64637, locations facility: Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland, city: Katowice, zip: 40-635, country: Poland, geoPoint lat: 50.25841, lon: 19.02754, locations facility: Jacek Legutko, city: Kraków, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, locations facility: Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland, city: Kraków, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, locations facility: 1st Military Hospital in Lublin, Lublin, Poland, city: Lubin, country: Poland, geoPoint lat: 51.40089, lon: 16.20149, locations facility: Department of Cardiology, Copper Health Centre (MCZ), city: Lubin, country: Poland, geoPoint lat: 51.40089, lon: 16.20149, locations facility: Clinical Department of Interventional Cardiology, Medical University of Lublin, city: Lublin, country: Poland, geoPoint lat: 51.25, lon: 22.56667, locations facility: Department of Cardiology, University Hospital, Institute of Medical Sciences, city: Opole, country: Poland, geoPoint lat: 50.67211, lon: 17.92533, locations facility: Department of Cardiology, Poznan University of Medical Sciences, city: Poznań, country: Poland, geoPoint lat: 52.40692, lon: 16.92993, locations facility: Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow, city: Rzeszów, country: Poland, geoPoint lat: 50.04132, lon: 21.99901, locations facility: 1st Department of Cardiology, Medical University of Warsaw, city: Warsaw, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Department of Cardiology and Internal Diseases, Military Institute of Medicine, city: Warsaw, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland, city: Warszawa, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, city: Warszawa, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Department of Invasive Cardiology, Wejherowo, city: Wejherowo, country: Poland, geoPoint lat: 54.60568, lon: 18.23559, locations facility: Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University, city: Wrocław, country: Poland, geoPoint lat: 51.1, lon: 17.03333, locations facility: Third Department of Cardiology, Medical University of Katowice, city: Zabrze, country: Poland, geoPoint lat: 50.32492, lon: 18.78576, hasResults: False