protocolSection identificationModule nctId: NCT06271590, orgStudyIdInfo id: CM-US-R03, briefTitle: MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels, acronym: MAGICAL-SV, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-04, completionDateStruct date: 2031-04, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Concept Medical Inc., class: INDUSTRY, collaborators name: Cardiovascular Research Foundation, New York, descriptionModule briefSummary: This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels in patients with coronary artery disease. The objective is to establish the safety and efficacy of the Magic TouchTM Drug coated balloon in treatment of small vessels (≤2.75 mm).A total of 1605 subjects will be enrolled in a maximum of 50 study sites located in North America. Additional sites located in Europe and South America may also participate in the study, with non-US sites contributing a maximum of \~50% of enrollees., conditionsModule conditions: Coronary Artery Disease, conditions: Native Coronary Artery Stenosis, conditions: Cardiovascular Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 2:1 randomized trial (MagicTouchTM Sirolimus-Coated Balloon VS Drug eluting stent (ZES or EES), primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1605, type: ESTIMATED, armsInterventionsModule interventions name: Sirolimus Drug Coated Balloon, interventions name: Drug eluting stents (DES), outcomesModule primaryOutcomes measure: Target lesion failure (TLF), secondaryOutcomes measure: Procedural success, secondaryOutcomes measure: Target lesion failure (TLF), secondaryOutcomes measure: Ischemia driven target vessel revascularization (ID-TVR), secondaryOutcomes measure: Target vessel revascularization (TVR), secondaryOutcomes measure: Any revascularization, secondaryOutcomes measure: Target vessel failure (TVF), secondaryOutcomes measure: Q-wave myocardial infarction (MI), secondaryOutcomes measure: Non Q-wave myocardial infarction (MI), secondaryOutcomes measure: Any myocardial infarction (MI), secondaryOutcomes measure: Target vessel myocardial infarction (TV MI), secondaryOutcomes measure: Spontaneous myocardial infarction (MI), secondaryOutcomes measure: Procedural myocardial infarction (MI), secondaryOutcomes measure: Cardiovascular mortality, secondaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: Cardiovascular mortality or myocardial infarction (MI), secondaryOutcomes measure: All-cause mortality or MI, secondaryOutcomes measure: All-cause mortality, myocardial infarction (MI) or target vessel revascularization (TVR), secondaryOutcomes measure: Any probable or definite stent thrombosis, secondaryOutcomes measure: Probable stent thrombosis, secondaryOutcomes measure: Definite stent thrombosis, otherOutcomes measure: Angina as assessed by SAQ-7 (Seattle Angina Questionnaire), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False