NCT07205068

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Tennessee Graduate School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-04
• Primary completion: 2026-11-04
• Completion: 2026-11-04
• First posted: 2025-10-03
• Last updated: 2025-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study