[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505528":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":13,"responsibleParty":41,"collaborators":43,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":7,"studyType":60,"phases":7,"briefSummary":61,"conditions":62,"keywords":7,"overallStatus":16,"whyStopped":7,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Baylor Research Institute","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","Shockwave Balloon","Intravascular lithotripsy (IVL) performed with the Shockwave balloon (Shockwave Medical Inc) enables treatment of calcified stenosis of the peripheral arteries by using sonic pressure waves to selectively disrupt superficial and deep calcium without impacting healthy tissue",[14],{"facility":15,"status":16,"city":17,"state":18,"zip":19,"country":20,"countryCode":21,"cosmosGeoPoint":22,"geoPoint":27,"contacts":28},"Baylor Scott and White Heart Hospital","RECRUITING","Plano","Texas","75093","United States","US",{"type":23,"coordinates":24},"Point",[25,26],-96.69889,33.01984,{"lat":26,"lon":25},[29,34,38],{"name":30,"role":31,"phone":32,"phoneExt":7,"email":33},"Denise Espinoza","CONTACT","4698144783","denise.espinoza@bswhealth.org",{"name":35,"role":31,"phone":36,"phoneExt":7,"email":37},"Sarah Hale","4698144845","sarah.hale@bswhealth.org",{"name":39,"role":40,"phone":7,"phoneExt":7,"email":7},"Karim Al-Azizi, MD","PRINCIPAL_INVESTIGATOR",{"type":42,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[44],{"name":45,"class":46},"Shockwave Medical, Inc.","INDUSTRY","100505528","intravascular-lithotripsy-in-high-risk-calcified-iliac-anatomy-for-transfemoral-tavr-100505528",false,"NCT05862558","Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR","ILIT","Inclusion Criteria:\n\n1. Age 18 to 90 years of age, inclusive, at the time of signing the informed consent\n2. Iliofemoral disease warrants treatment, per routine guidelines (greater than 50% stenosis and heavy calcification of the iliac's).\n3. Severe symptomatic aortic stenosis and undergoing a planned TAVR procedure\n4. Prohibitive iliofemoral disease, as determined by the diagnostic CT abdomen and pelvis.\n5. Subjects can provide written, informed consent.\n\nExclusion Criteria:\n\n1. Subject is participating in another research study involving an investigational agent that has not reached the primary endpoint.\n2. Subject who has contraindications to IVL\n3. Subject who has contraindications or is not eligible for TAVR","ALL","18 Years","90 Years",{"count":58,"type":59},50,"ESTIMATED","OBSERVATIONAL","To assess the efficacy and safety of Intravascular Lithotripsy (IVL) in subjects undergoing transfemoral TAVR in patients with severe iliac disease, prohibitive for transfemoral TAVR in patients with severe symptomatic aortic stenosis, otherwise considered for alternative access TAVR. (e.g. trans-carotid)",[63,64],"Iliac Disease","Aortic Valve Stenosis","2026-08-19",{"date":67,"type":68},"2026-08-21","ACTUAL",{"date":70,"type":68},"2023-03-30",{"date":72,"type":59},"2027-10-01",{"name":5,"class":6},1]