An interventional study of Shockwave M5 IVL Catheter and Modified Seldinger Technique in Aortic Stenosis, sponsored by University of Tennessee Graduate School of Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by University of Tennessee Graduate School of Medicine · Not applicable, Interventional, and Treatment
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)
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:
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →University of Tennessee Graduate School of Medicine is the lead sponsor of 26 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Procedure: Modified Seldinger Technique
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
The Shockwave M5 IVL Catheter is a balloon catheter designed to modify calcified arterial plaque using intravascular lithotripsy prior to vascular access
Standard of care for femoral access in patients with calcified femoral arteries
Standard femoral artery access using the modified Seldinger technique without any prior vessel preparation or plaque modification.
Evaluate for contrast extravasation post closure of femoral artery at the end of the procedure
Time frame: Immediately post-procedure
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
As part of evaluating clinical deterioration, this outcome measures the drop in hemoglobin (g/dL)
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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.
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
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
Time frame: Up to 3 months post-procedure
Failure of treatment
Failure to achieve the intended procedural outcomes or additional interventions due to complications
Time frame: Day 0 to discharge (or up to 3 days post-procedure)
Number of related AE(s)
Time frame: Up to 3 months post-procedure
Number of related SAE(S)
Time frame: Up to 3 months post-procedure
Side effects reported by subjects or observed by study team
Time frame: Within 3 days post-procedure, or up to 3 months
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University of Tennessee Graduate School of Medicine