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NCT Number: NCT07205068

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)

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location status: Recruiting

Location contact

Raj Baljepally, MD

PRINCIPAL_INVESTIGATOR

Savannah Allen, MPH Study Coordinator

CONTACT

[email protected]

+1865-305-9522

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unable to understand study procedures
  • Unwilling to give consent
  • Patients with cognitive impairments that can affect their ability to give consent
  • Unfavorable calcium distribution of femoral artery

Treatment and study plan

Shockwave M5 IVL Catheter

Device

The Shockwave M5 IVL Catheter is a balloon catheter designed to modify calcified arterial plaque using intravascular lithotripsy prior to vascular access

modified Seldinger technique

Procedure

Standard of care for femoral access in patients with calcified femoral arteries

Primary outcomes

  1. Evaluate for contrast extravasation post closure of femoral artery at the end of the procedure

    Time frame: Immediately post-procedure

Secondary outcomes

  1. Determine need for Vascular surgery consultation

    Time frame: During hospital stay (Day 0-3)

  2. If vascular complication, was PTA, stenting, or open surgery used

    Time frame: During hospital stay (Day 0-3)

  3. Number of perclose devices used to close the femoral artery access site

    Time frame: During procedure (Day 0)

  4. Determine presence of other vascular complications I.e. bleeding, hematoma, emboli etc

    Time frame: Within 3 days post-procedure

  5. Change in Hemoglobin

    Time frame: Day 0 to Day 3 post-procedure

    As part of evaluating clinical deterioration, this outcome measures the drop in hemoglobin (g/dL)

  6. Change in Serum Creatinine

    Time frame: Day 0 to Day 3 post procedure

    As part of evaluating clinical deterioration, this outcome assesses the increase in serum creatinine (mg/dL)

  7. Incidence of Hypotension or Shock

    Time frame: Day 0 to Day 3 post-procedure

    As part of evaluating clinical deterioration, this outcome captures the number of participants who develop hypotension (SBP < 90 mmHg) or clinical shock.

  8. Incidence of Infections or Sepsis

    Time frame: Day 0 to Day 3 post-procedure

    As part of evaluating clinical deterioration, this outcome records the number of participants diagnosed with infection or sepsis

  9. Determine if there is a difference between hospital length of stay

    Time frame: From date of admission to date of discharge, assessed up to 60 days

    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.

  10. Assess for difference in pain/numbness in distal extremities post-procedure (Yes/No)

    Time frame: Within 3 days post-procedure

  11. Assess for differences in mortality related to complications between the groups

    Time frame: Up to 3 months post-procedure

    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

  12. Failure of treatment

    Time frame: Day 0 to discharge (or up to 3 days post-procedure)

    Failure to achieve the intended procedural outcomes or additional interventions due to complications

  13. Number of related AE(s)

    Time frame: Up to 3 months post-procedure

  14. Number of related SAE(S)

    Time frame: Up to 3 months post-procedure

  15. Side effects reported by subjects or observed by study team

    Time frame: Within 3 days post-procedure, or up to 3 months

Sponsors and collaborators

Lead sponsor

University of Tennessee Graduate School of Medicine

Other

Collaborators

  • Shockwave Medical, Inc.

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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