[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608708":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":35,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":67,"sex":71,"minAge":72,"maxAge":26,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":38,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"University of Tennessee Graduate School of Medicine","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Shockwave model (M5) Intravascular Lithotripsy (IVL)","EXPERIMENTAL","Patients will be treated with the Shockwave M5 Intravascular Lithotripsy (IVL) device prior to femoral artery access using the modified Seldinger technique",[13,14],"Device: Shockwave M5 IVL Catheter","Procedure: Modified Seldinger Technique",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard femoral access","ACTIVE_COMPARATOR","Patients will receive standard femoral artery access via the modified Seldinger approach without utilizing intravascular lithotripsy in heavily calcified femoral arteries",[14],[21,27,32],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Shockwave M5 IVL Catheter","The Shockwave M5 IVL Catheter is a balloon catheter designed to modify calcified arterial plaque using intravascular lithotripsy prior to vascular access",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Modified Seldinger Technique","Standard of care for femoral access in patients with calcified femoral arteries",[9],{"type":28,"name":29,"description":33,"armGroupLabels":34,"otherNames":26},"Standard femoral artery access using the modified Seldinger technique without any prior vessel preparation or plaque modification.",[16],[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"University of Tennessee Medical Center","RECRUITING","Knoxville","Tennessee","37920","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-83.92074,35.96064,{"lat":48,"lon":47},[51,56],{"name":52,"role":53,"phone":54,"phoneExt":26,"email":55},"Savannah Allen, MPH Study Coordinator","CONTACT","+1865-305-9522","skallen1@utmck.edu",{"name":57,"role":58,"phone":26,"phoneExt":26,"email":26},"Raj Baljepally, MD","PRINCIPAL_INVESTIGATOR",{"type":60,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[62],{"name":63,"class":64},"Shockwave Medical, Inc.","INDUSTRY","100608708","improved-outcomes-with-pre-procedure-shockwave-ivl-of-common-femoral-artery-access-site-prior-to-large-bore-access-and-pre-closure-100608708",false,"NCT07205068","Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure","Inclusion Criteria:\n\n1. \\>18 years of age\n2. Patient with a diagnosis of severe aortic stenosis undergoing TAVR\n3. Participants must be able to read and understand study procedures\n4. Willing to participate and sign an ICF\n5. Patients with \\> 90-degree arc of calcium at the large bore access site per CT documentation\n\nExclusion Criteria:\n\n1. Unable to understand study procedures\n2. Unwilling to give consent\n3. Patients with cognitive impairments that can affect their ability to give consent\n4. Unfavorable calcium distribution of femoral artery","ALL","18 Years",{"count":74,"type":75},100,"ESTIMATED","INTERVENTIONAL",[78],"NA","The primary purpose of this study is to observe reduced access site complications in patients with heavily calcified common femoral arteries requiring Transcatheter Aortic Valve Replacement (TAVR)",[81],"Aortic Stenosis",[81,83],"Transcatheter aortic valve replacement","2025-09-30",{"date":86,"type":87},"2025-10-03","ACTUAL",{"date":89,"type":75},"2025-10-04",{"date":91,"type":75},"2026-11-04",{"name":5,"class":6},1]