[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642512":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":7,"responsibleParty":19,"collaborators":7,"id":21,"slug":22,"hasResults":23,"nctId":24,"briefTitle":25,"officialTitle":26,"acronym":27,"eligibilityCriteria":28,"healthyVolunteers":23,"sex":29,"minAge":30,"maxAge":7,"enrollmentInfo":31,"targetDuration":34,"studyType":35,"phases":7,"briefSummary":36,"conditions":37,"keywords":7,"overallStatus":41,"whyStopped":7,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":7},{"fullName":5,"class":6},"Minneapolis Heart Institute Foundation","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","non compliant balloon","This is a registry tracking the use and outcomes of the OPN NC balloon, a non-compliant balloon",[14],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Bavana V Rangan, BDS, MPH","CONTACT","612-863-4768","Bavana.Rangan@allina.com",{"type":20,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100642512","opn-balloon-for-safe-recanalization-of-calcified-coronary-lesions-100642512",false,"NCT07646444","OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions","OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions (OPEN-SAFE Registry)","OPEN-SAFE","Inclusion Criteria:\n\n* Age 18 years or older\n* Subjects who underwent a clinically indicated PCI procedure that involved at least one OPN balloon\n* Date range for data collection will be from February 1, 2023 to December 31, 2028\n\nExclusion Criteria:\n\n* Subjects who have opted out of being included in research related data collection","ALL","18 Years",{"count":32,"type":33},300,"ESTIMATED","1 Week","OBSERVATIONAL","The goal of the OPEN-SAFE registry is to describe the contemporary use and outcomes of SIS-OPN in North America.",[38,39,40],"Coronary Arterial Disease (CAD)","In Stent Restenosis","Calcified Coronary Lesions","NOT_YET_RECRUITING","2026-06-10",{"date":44,"type":45},"2026-06-12","ACTUAL",{"date":47,"type":33},"2026-06",{"date":49,"type":33},"2027-06",{"name":5,"class":6}]