NCT07205068 · University of Tennessee Graduate School of Medicine
Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure
What this study is 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)
View original scientific description
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)
Interventions
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.
Primary outcome measures
Evaluate for contrast extravasation post closure of femoral artery at the end of the procedure
Time frame: Immediately post-procedure
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- \>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
Exclusion criteria
- 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
Where
- Knoxville, Tennessee
Collaborators
Shockwave Medical, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 3, 2025 · Source of record for eligibility and locations