Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure

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)

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis
• Intervention / Treatment: Device: Shockwave M5 IVL Catheter; Procedure: Modified Seldinger Technique; Procedure: Modified Seldinger Technique

Detailed Description

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.

The secondary purposes of this study are to:

1. Determine the clinical outcomes between groups
2. Distinguish extravasation post closure at the end of the procedure
3. Compare the need for open vascular surgery between groups
4. Examine PTA or Stents to the CFA to help hemostasis or local vascular complications between groups
5. Number of Perclose devices used between groups
6. Compare Bleeding/Hematoma between groups
7. Examine the difference in hospital length of stay between groups
8. Examine renal function post procedure
9. Difference in pain or numbness in the distal extremity between groups
10. Mortality related to complications from vascular closure site between groups
11. Conversion to general anesthesia due to additional procedures required to address the CFA access site complications between groups

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Recruiting
      • University of Tennessee Medical Center
      • Principal Investigator: Raj Baljepally, MD
      • Contact: Savannah Allen, MPH Study Coordinator; Phone Number: +1865-305-9522; Email: skallen1@utmck.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. >18 years of age
2. Patient with a diagnosis of severe aortic stenosis undergoing TAVR
3. Participants must be able to read and understand study procedures
4. Willing to participate and sign an ICF
5. Patients with > 90-degree arc of calcium at the large bore access site per CT documentation

Exclusion Criteria:

1. Unable to understand study procedures
2. Unwilling to give consent
3. Patients with cognitive impairments that can affect their ability to give consent
4. Unfavorable calcium distribution of femoral artery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shockwave model (M5) Intravascular Lithotripsy (IVL); Patients will be treated with the Shockwave M5 Intravascular Lithotripsy (IVL) device prior to femoral artery access using the modified Seldinger technique	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; Procedure: Modified Seldinger Technique; Standard of care for femoral access in patients with calcified femoral arteries; Procedure: Modified Seldinger Technique; Standard femoral artery access using the modified Seldinger technique without any prior vessel preparation or plaque modification.
Active Comparator: Standard femoral access; Patients will receive standard femoral artery access via the modified Seldinger approach without utilizing intravascular lithotripsy in heavily calcified femoral arteries	Procedure: Modified Seldinger Technique; Standard of care for femoral access in patients with calcified femoral arteries; Procedure: Modified Seldinger Technique; Standard femoral artery access using the modified Seldinger technique without any prior vessel preparation or plaque modification.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate for contrast extravasation post closure of femoral artery at the end of the procedure	Immediately post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine need for Vascular surgery consultation		During hospital stay (Day 0-3)
If vascular complication, was PTA, stenting, or open surgery used		During hospital stay (Day 0-3)
Number of perclose devices used to close the femoral artery access site		During procedure (Day 0)
Determine presence of other vascular complications I.e. bleeding, hematoma, emboli etc		Within 3 days post-procedure
Change in Hemoglobin	As part of evaluating clinical deterioration, this outcome measures the drop in hemoglobin (g/dL)	Day 0 to Day 3 post-procedure
Change in Serum Creatinine	As part of evaluating clinical deterioration, this outcome assesses the increase in serum creatinine (mg/dL)	Day 0 to Day 3 post procedure
Incidence of Hypotension or Shock	As part of evaluating clinical deterioration, this outcome captures the number of participants who develop hypotension (SBP < 90 mmHg) or clinical shock.	Day 0 to Day 3 post-procedure
Incidence of Infections or Sepsis	As part of evaluating clinical deterioration, this outcome records the number of participants diagnosed with infection or sepsis	Day 0 to Day 3 post-procedure
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
Assess for difference in pain/numbness in distal extremities post-procedure (Yes/No)		Within 3 days post-procedure
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
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)
Number of related AE(s)		Up to 3 months post-procedure
Number of related SAE(S)		Up to 3 months post-procedure
Side effects reported by subjects or observed by study team		Within 3 days post-procedure, or up to 3 months

Collaborators and Investigators

• Sponsor: University of Tennessee Graduate School of Medicine
• Collaborators: Shockwave Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): October 4, 2025
• Primary Completion (Estimated): November 4, 2026
• Study Completion (Estimated): November 4, 2026

Study Registration Dates

• First Submitted: August 21, 2025
• First Submitted That Met QC Criteria: September 30, 2025
• First Posted (Estimated): October 3, 2025

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Aortic Stenosis; Transcatheter aortic valve replacement
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 5319; Institutional Review Board (Other Identifier: The University of Tennessee Health Science Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes