protocolSection identificationModule nctId: NCT06369142, orgStudyIdInfo id: GE IDE No. L00123, briefTitle: Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy, acronym: ISAR-WAVE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2027-07-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Deutsches Herzzentrum Muenchen, class: OTHER, collaborators name: Gemeinsamer Bundesaussschuss, collaborators name: EvidentIQ Germany GmbH, collaborators name: Monitoring Services GmbH, collaborators name: Institute of AI and Informatics in Medicine Technical University of Munich, descriptionModule briefSummary: The clinical trial is intended to evaluate the efficacy, safety and economic benefit of coronary lithotripsy compared to other additional procedures (cutting or super high pressure balloon angioplasty, ablative procedures) in lesion preparation and interventional treatment of severely calcified coronary stenoses., conditionsModule conditions: Coronary Artery Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The study participant as well as the follow-up physicians and site personal are blinded., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 666, type: ESTIMATED, armsInterventionsModule interventions name: Intravascular lithotripsy (IVL), interventions name: Standard non-IVL methods, outcomesModule primaryOutcomes measure: Combined endpoint of major cardiac and cerebrovascular events, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Cardiac mortality, secondaryOutcomes measure: Non-fatal myocardial infarction, secondaryOutcomes measure: Non-fatal stroke, secondaryOutcomes measure: Clinically indicated target vessel revascularization, secondaryOutcomes measure: Definite stent thrombosis, secondaryOutcomes measure: Clinically indicated non-target vessel revascularization, secondaryOutcomes measure: Hospitalization due to acute coronary syndrome, secondaryOutcomes measure: Symptoms of coronary heart disease (CHD): physical health status, secondaryOutcomes measure: Symptoms of CHD: mental health status, secondaryOutcomes measure: Bleeding during index hospitalization or ≤30 days (BARC 3-5), secondaryOutcomes measure: Procedural failure (failed application of study-related additional procedure, final TIMI flow <3, >30% residual stenosis, vessel perforation, stent loss, stent delivery failure), secondaryOutcomes measure: Medical costs (index hospitalization and costs for re-hospitalization due to acute coronary syndrome), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Deutsches Herzzentrum München, city: Munich, state: Bavaria, zip: 80636, country: Germany, contacts name: Salvatore Cassese, MD, PHD, role: CONTACT, phone: 0049891218, phoneExt: 2764, email: cassese@dhm.mhn.de, contacts name: Salvatore Cassese, MD, PDH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.13743, lon: 11.57549, hasResults: False