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

NCT ID: NCT07205068

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-04
• Study Completion Date: 2026-11-04

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Shockwave model (M5) Intravascular Lithotripsy (IVL)

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

Group Type: EXPERIMENTAL

Shockwave M5 IVL Catheter

Intervention Type: DEVICE

The Shockwave M5 IVL Catheter is a balloon catheter designed to modify calcified arterial plaque using intravascular lithotripsy prior to vascular access

Modified Seldinger Technique

Intervention Type: PROCEDURE

Standard of care for femoral access in patients with calcified femoral arteries

Standard femoral access

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

Group Type: ACTIVE_COMPARATOR

Modified Seldinger Technique

Intervention Type: PROCEDURE

Standard femoral artery access using the modified Seldinger technique without any prior vessel preparation or plaque modification.

Interventions

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

Intervention Type: DEVICE

Modified Seldinger Technique

Standard of care for femoral access in patients with calcified femoral arteries

Intervention Type: PROCEDURE

Modified Seldinger Technique

Standard femoral artery access using the modified Seldinger technique without any prior vessel preparation or plaque modification.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shockwave Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Tennessee Graduate School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Savannah Allen, MPH Study Coordinator

Role: primary

skallen1@utmck.edu

+1865-305-9522

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Institutional Review Board

Identifier Type: OTHER

Identifier Source: secondary_id

5319

Identifier Type: -

Identifier Source: org_study_id