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

NCT07205068 | Recruiting FDA Device

• 2 other identifiers: 5319Institutional Review Board
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Conditions

Aortic Stenosis

Keywords

Aortic Stenosis; Transcatheter aortic valve replacement

Outcome Measures

Primary Outcomes (1)

• Evaluate for contrast extravasation post closure of femoral artery at the end of the procedure

  Immediately post-procedure

Secondary Outcomes (15)

• Determine need for Vascular surgery consultation

  During hospital stay (Day 0-3)

• If vascular complication, was PTA, stenting, or open surgery used

  During hospital stay (Day 0-3)

• Number of perclose devices used to close the femoral artery access site

  During procedure (Day 0)

• Determine presence of other vascular complications I.e. bleeding, hematoma, emboli etc

  Within 3 days post-procedure

• Change in Hemoglobin

  Day 0 to Day 3 post-procedure

Study Arms (2)

Shockwave model (M5) Intravascular Lithotripsy (IVL)

EXPERIMENTAL

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

Standard femoral access

ACTIVE COMPARATOR

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

Interventions

Shockwave M5 IVL Catheter DEVICE

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

Shockwave model (M5) Intravascular Lithotripsy (IVL)

Modified Seldinger Technique PROCEDURE

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

Shockwave model (M5) Intravascular Lithotripsy (IVL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years of age
• Patient with a diagnosis of severe aortic stenosis undergoing TAVR
• Participants must be able to read and understand study procedures
• Willing to participate and sign an ICF
• Patients with \> 90-degree arc of calcium at the large bore access site per CT documentation

You may not qualify if:

• Unable to understand study procedures
• Unwilling to give consent
• Patients with cognitive impairments that can affect their ability to give consent
• Unfavorable calcium distribution of femoral artery

Sponsors & Collaborators

• University of Tennessee Graduate School of Medicine: lead
• Shockwave Medical, Inc.: collaborator

Study Sites (1)

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: October 3, 2025
• Study Start: October 4, 2025
• Primary Completion (Estimated): November 4, 2026
• Study Completion (Estimated): November 4, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-08

Locations

US (1)