Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Shockwave M5 IVL Catheter, Modified Seldinger Technique, Modified Seldinger Technique.
- Who it may be relevant to
- Registry conditions: Aortic Stenosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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)
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
Interventions
- 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.
Primary outcome measures
- Evaluate for contrast extravasation post closure of femoral artery at the end of the procedure [Time frame: Immediately post-procedure]
Secondary outcome measures (12)
- Determine need for Vascular surgery consultation [Time frame: During hospital stay (Day 0-3)]
- If vascular complication, was PTA, stenting, or open surgery used [Time frame: During hospital stay (Day 0-3)]
- Number of perclose devices used to close the femoral artery access site [Time frame: During procedure (Day 0)]
- Determine presence of other vascular complications I.e. bleeding, hematoma, emboli etc [Time frame: Within 3 days post-procedure]
- Change in Hemoglobin [Time frame: Day 0 to Day 3 post-procedure]
- Change in Serum Creatinine [Time frame: Day 0 to Day 3 post procedure]
- Incidence of Hypotension or Shock [Time frame: Day 0 to Day 3 post-procedure]
- Incidence of Infections or Sepsis [Time frame: Day 0 to Day 3 post-procedure]
- 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]
- Assess for difference in pain/numbness in distal extremities post-procedure (Yes/No) [Time frame: Within 3 days post-procedure]
- Assess for differences in mortality related to complications between the groups [Time frame: Up to 3 months post-procedure]
- Failure of treatment [Time frame: Day 0 to discharge (or up to 3 days post-procedure)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Tennessee Medical Center — Knoxville
Identifiers
NCT: NCT07205068 · 5319 · Institutional Review Board