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

University of Tennessee Graduate School of Medicine

Status: Enrolling

Conditions: Aortic Stenosis

Treatments: Procedure: Modified Seldinger Technique; Device: Shockwave M5 IVL Catheter

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07205068

5319

Institutional Review Board (Other Identifier)

Details and patient eligibility

About

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)

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Shockwave model (M5) Intravascular Lithotripsy (IVL)

Experimental group

Description:

Patients will be treated with the Shockwave M5 Intravascular Lithotripsy (IVL) device prior to femoral artery access using the modified Seldinger technique

Treatment:

Procedure: Modified Seldinger Technique

Procedure: Modified Seldinger Technique

Device: Shockwave M5 IVL Catheter

Standard femoral access

Active Comparator group

Description:

Patients will receive standard femoral artery access via the modified Seldinger approach without utilizing intravascular lithotripsy in heavily calcified femoral arteries

Treatment:

Procedure: Modified Seldinger Technique

Procedure: Modified Seldinger Technique