Shockwave IVL of the common femoral artery before large-bore TAVR access and closure
Official title: Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure
Run by University of Tennessee Graduate School of Medicine · NCT07205068 · Data updated 2026-11-12
This will test whether using Shockwave intravascular lithotripsy on heavily calcified common femoral arteries before TAVR lowers access-site complications for adults with severe aortic stenosis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Tennessee Graduate School of Medicine Academic / other |
| Locations | 1 site (Knoxville, Tennessee) |
| Status | Recruiting |
| Started | October 4, 2025 |
| Main results expected | October 4, 2028 |
| Study ends | October 4, 2028 |
| Registry record updated | August 17, 2026 |
| Trial ID | NCT07205068 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with severe aortic stenosis scheduled for TAVR who have CT-confirmed heavy common femoral artery calcification (>90-degree arc) and can give informed consent are ideal candidates.
✕Probably not a fit
Patients without significant femoral calcification, with unfavorable calcium distribution for IVL, who require non-femoral access, or who cannot consent are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective randomized pilot comparing pre-access Shockwave M5 intravascular lithotripsy (IVL) plus modified Seldinger access versus standard modified Seldinger access without IVL for patients undergoing TAVR with heavily calcified common femoral arteries. Participants are randomized at the University of Tennessee Medical Center and followed for procedural and post-procedural vascular outcomes. The primary focus is on reducing access-site complications, and multiple secondary endpoints include need for open vascular surgery, use of adjunctive PTA or stents, bleeding/hematoma, number of Perclose devices used, length of stay, renal function, distal limb symptoms, and conversion to general anesthesia. Enrollment requires CT-documented heavy femoral calcification (>90-degree arc) and informed consent.
Why it matters
Potential benefit: If successful, using IVL before access could reduce bleeding and vascular complications, decrease the need for surgical repair, and shorten hospital stays after TAVR.
How similar studies have gone: Observational and registry reports suggest IVL can facilitate large-bore femoral access and reduce complications, but randomized controlled evidence is limited, making this a relatively novel randomized test of the approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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University of Tennessee Medical Center
Knoxville, Tennessee, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.