[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608708":3},{"organization":4,"outcomesModule":7,"designInfo":60,"detailedDescription":66,"studyPopulation":11,"armGroups":67,"interventions":80,"overallOfficials":11,"centralContacts":11,"locations":94,"responsibleParty":118,"collaborators":120,"id":124,"slug":11,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":11,"eligibilityCriteria":128,"healthyVolunteers":125,"sex":129,"minAge":130,"maxAge":11,"enrollmentInfo":131,"targetDuration":11,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":97,"whyStopped":11,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"University of Tennessee Graduate School of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Evaluate for contrast extravasation post closure of femoral artery at the end of the procedure",null,"Immediately post-procedure",[14,17,19,22,25,29,33,36,39,43,45,49,53,55,57],{"measure":15,"description":11,"timeFrame":16},"Determine need for Vascular surgery consultation","During hospital stay (Day 0-3)",{"measure":18,"description":11,"timeFrame":16},"If vascular complication, was PTA, stenting, or open surgery used",{"measure":20,"description":11,"timeFrame":21},"Number of perclose devices used to close the femoral artery access site","During procedure (Day 0)",{"measure":23,"description":11,"timeFrame":24},"Determine presence of other vascular complications I.e. bleeding, hematoma, emboli etc","Within 3 days post-procedure",{"measure":26,"description":27,"timeFrame":28},"Change in Hemoglobin","As part of evaluating clinical deterioration, this outcome measures the drop in hemoglobin (g\u002FdL)","Day 0 to Day 3 post-procedure",{"measure":30,"description":31,"timeFrame":32},"Change in Serum Creatinine","As part of evaluating clinical deterioration, this outcome assesses the increase in serum creatinine (mg\u002FdL)","Day 0 to Day 3 post procedure",{"measure":34,"description":35,"timeFrame":28},"Incidence of Hypotension or Shock","As part of evaluating clinical deterioration, this outcome captures the number of participants who develop hypotension (SBP \\\u003C 90 mmHg) or clinical shock.",{"measure":37,"description":38,"timeFrame":28},"Incidence of Infections or Sepsis","As part of evaluating clinical deterioration, this outcome records the number of participants diagnosed with infection or sepsis",{"measure":40,"description":41,"timeFrame":42},"Determine if there is a difference between hospital length of stay","Hospital length of stay will be measured in days from the date of admission to the date of discharge. The total duration will be compared between the intervention and control groups.","From date of admission to date of discharge, assessed up to 60 days",{"measure":44,"description":11,"timeFrame":24},"Assess for difference in pain\u002Fnumbness in distal extremities post-procedure (Yes\u002FNo)",{"measure":46,"description":47,"timeFrame":48},"Assess for differences in mortality related to complications between the groups","Presence of new or worsening pain or numbness in the distal extremities will be assessed by patient-reported symptoms during routine clinical evaluation and physical examination. If present, symptoms will be documented in medical records","Up to 3 months post-procedure",{"measure":50,"description":51,"timeFrame":52},"Failure of treatment","Failure to achieve the intended procedural outcomes or additional interventions due to complications","Day 0 to discharge (or up to 3 days post-procedure)",{"measure":54,"description":11,"timeFrame":48},"Number of related AE(s)",{"measure":56,"description":11,"timeFrame":48},"Number of related SAE(S)",{"measure":58,"description":11,"timeFrame":59},"Side effects reported by subjects or observed by study team","Within 3 days post-procedure, or up to 3 months",{"allocation":61,"interventionModel":62,"interventionModelDescription":11,"primaryPurpose":63,"observationalModel":11,"timePerspective":11,"maskingInfo":64},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":65,"maskingDescription":11,"whoMasked":11},"NONE","This is a prospective randomized\u002Fcontrol trial pilot study to compare clinical outcomes of common femoral artery access in patients undergoing TAVR at the University of Tennessee Medical. Specifically, This study compares patients utilizing the Shockwave model (M5) Intravascular Lithotripsy (IVL) prior to standard arterial access using the modified Seldinger technique to those utilizing the standard femoral artery access via the modified Seldinger approach without the utilization of intravascular lithotripsy in heavily calcified femoral arteries.\n\nThe secondary purposes of this study are to:\n\n1. Determine the clinical outcomes between groups\n2. Distinguish extravasation post closure at the end of the procedure\n3. Compare the need for open vascular surgery between groups\n4. Examine PTA or Stents to the CFA to help hemostasis or local vascular complications between groups\n5. Number of Perclose devices used between groups\n6. Compare Bleeding\u002FHematoma between groups\n7. Examine the difference in hospital length of stay between groups\n8. Examine renal function post procedure\n9. Difference in pain or numbness in the distal extremity between groups\n10. Mortality related to complications from vascular closure site between groups\n11. Conversion to general anesthesia due to additional procedures required to address the CFA access site complications between groups",[68,75],{"label":69,"type":70,"description":71,"interventionNames":72},"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",[73,74],"Device: Shockwave M5 IVL Catheter","Procedure: Modified Seldinger Technique",{"label":76,"type":77,"description":78,"interventionNames":79},"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",[74],[81,86,91],{"type":82,"name":83,"description":84,"armGroupLabels":85,"otherNames":11},"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",[69],{"type":87,"name":88,"description":89,"armGroupLabels":90,"otherNames":11},"PROCEDURE","Modified Seldinger Technique","Standard of care for femoral access in patients with calcified femoral arteries",[69],{"type":87,"name":88,"description":92,"armGroupLabels":93,"otherNames":11},"Standard femoral artery access using the modified Seldinger technique without any prior vessel preparation or plaque modification.",[76],[95],{"facility":96,"status":97,"city":98,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"University of Tennessee Medical Center","RECRUITING","Knoxville","Tennessee","37920","United States","US",{"type":104,"coordinates":105},"Point",[106,107],-83.92074,35.96064,{"lat":107,"lon":106},[110,115],{"name":111,"role":112,"phone":113,"phoneExt":11,"email":114},"Savannah Allen, MPH Study Coordinator","CONTACT","+1865-305-9522","skallen1@utmck.edu",{"name":116,"role":117,"phone":11,"phoneExt":11,"email":11},"Raj Baljepally, MD","PRINCIPAL_INVESTIGATOR",{"type":119,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[121],{"name":122,"class":123},"Shockwave Medical, Inc.","INDUSTRY","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":132,"type":133},100,"ESTIMATED","INTERVENTIONAL",[136],"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)",[139],"Aortic Stenosis",[139,141],"Transcatheter aortic valve replacement","2025-09-30",{"date":144,"type":145},"2025-10-03","ACTUAL",{"date":147,"type":133},"2025-10-04",{"date":149,"type":133},"2026-11-04",{"name":5,"class":6},1]