Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-25 @ 3:15 PM
Study NCT ID:
NCT07205068
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-11-04', 'size': 232605, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-22T12:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-11-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2025-08-21', 'studyFirstSubmitQcDate': '2025-09-30', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate for contrast extravasation post closure of femoral artery at the end of the procedure', 'timeFrame': 'Immediately post-procedure'}], 'secondaryOutcomes': [{'measure': 'Determine need for Vascular surgery consultation', 'timeFrame': 'During hospital stay (Day 0-3)'}, {'measure': 'If vascular complication, was PTA, stenting, or open surgery used', 'timeFrame': 'During hospital stay (Day 0-3)'}, {'measure': 'Number of perclose devices used to close the femoral artery access site', 'timeFrame': 'During procedure (Day 0)'}, {'measure': 'Determine presence of other vascular complications I.e. bleeding, hematoma, emboli etc', 'timeFrame': 'Within 3 days post-procedure'}, {'measure': 'Change in Hemoglobin', 'timeFrame': 'Day 0 to Day 3 post-procedure', 'description': 'As part of evaluating clinical deterioration, this outcome measures the drop in hemoglobin (g/dL)'}, {'measure': 'Change in Serum Creatinine', 'timeFrame': 'Day 0 to Day 3 post procedure', 'description': 'As part of evaluating clinical deterioration, this outcome assesses the increase in serum creatinine (mg/dL)'}, {'measure': 'Incidence of Hypotension or Shock', 'timeFrame': 'Day 0 to Day 3 post-procedure', 'description': 'As part of evaluating clinical deterioration, this outcome captures the number of participants who develop hypotension (SBP \\< 90 mmHg) or clinical shock.'}, {'measure': 'Incidence of Infections or Sepsis', 'timeFrame': 'Day 0 to Day 3 post-procedure', 'description': 'As part of evaluating clinical deterioration, this outcome records the number of participants diagnosed with infection or sepsis'}, {'measure': 'Determine if there is a difference between hospital length of stay', 'timeFrame': 'From date of admission to date of discharge, assessed up to 60 days', 'description': '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.'}, {'measure': 'Assess for difference in pain/numbness in distal extremities post-procedure (Yes/No)', 'timeFrame': 'Within 3 days post-procedure'}, {'measure': 'Assess for differences in mortality related to complications between the groups', 'timeFrame': 'Up to 3 months post-procedure', 'description': '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'}, {'measure': 'Failure of treatment', 'timeFrame': 'Day 0 to discharge (or up to 3 days post-procedure)', 'description': 'Failure to achieve the intended procedural outcomes or additional interventions due to complications'}, {'measure': 'Number of related AE(s)', 'timeFrame': 'Up to 3 months post-procedure'}, {'measure': 'Number of related SAE(S)', 'timeFrame': 'Up to 3 months post-procedure'}, {'measure': 'Side effects reported by subjects or observed by study team', 'timeFrame': 'Within 3 days post-procedure, or up to 3 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Aortic Stenosis', 'Transcatheter aortic valve replacement'], 'conditions': ['Aortic Stenosis']}, 'descriptionModule': {'briefSummary': '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)', 'detailedDescription': 'This is a prospective randomized/control 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/Hematoma 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT07205068', 'briefTitle': 'Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure', 'organization': {'class': 'OTHER', 'fullName': 'University of Tennessee Graduate School of Medicine'}, 'officialTitle': 'Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure', 'orgStudyIdInfo': {'id': '5319'}, 'secondaryIdInfos': [{'id': 'Institutional Review Board', 'type': 'OTHER', 'domain': 'The University of Tennessee Health Science Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shockwave model (M5) Intravascular Lithotripsy (IVL)', 'description': 'Patients will be treated with the Shockwave M5 Intravascular Lithotripsy (IVL) device prior to femoral artery access using the modified Seldinger technique', 'interventionNames': ['Device: Shockwave M5 IVL Catheter', 'Procedure: Modified Seldinger Technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard femoral access', 'description': 'Patients will receive standard femoral artery access via the modified Seldinger approach without utilizing intravascular lithotripsy in heavily calcified femoral arteries', 'interventionNames': ['Procedure: Modified Seldinger Technique']}], 'interventions': [{'name': 'Shockwave M5 IVL Catheter', 'type': 'DEVICE', 'description': 'The Shockwave M5 IVL Catheter is a balloon catheter designed to modify calcified arterial plaque using intravascular lithotripsy prior to vascular access', 'armGroupLabels': ['Shockwave model (M5) Intravascular Lithotripsy (IVL)']}, {'name': 'Modified Seldinger Technique', 'type': 'PROCEDURE', 'description': 'Standard of care for femoral access in patients with calcified femoral arteries', 'armGroupLabels': ['Shockwave model (M5) Intravascular Lithotripsy (IVL)']}, {'name': 'Modified Seldinger Technique', 'type': 'PROCEDURE', 'description': 'Standard femoral artery access using the modified Seldinger technique without any prior vessel preparation or plaque modification.', 'armGroupLabels': ['Standard femoral access']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Savannah Allen, MPH Study Coordinator', 'role': 'CONTACT', 'email': 'skallen1@utmck.edu', 'phone': '+1865-305-9522'}, {'name': 'Raj Baljepally, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Tennessee Medical Center', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tennessee Graduate School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shockwave Medical, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}