Aortic StenosisNCT07205068
Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure
A study testing Shockwave M5 IVL Catheter and Modified Seldinger Technique in people with Aortic Stenosis, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Shockwave M5 IVL Catheter and Modified Seldinger Technique
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2025to 4 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Savannah Allen, MPH Study Coordinator, +1865-305-9522, skallen1@utmck.edu
Raj Baljepally, MD
About this study
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)
Read the 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:
- Determine the clinical outcomes between groups
- Distinguish extravasation post closure at the end of the procedure
- Compare the need for open vascular surgery between groups
- Examine PTA or Stents to the CFA to help hemostasis or local vascular complications between groups
- Number of Perclose devices used between groups
- Compare Bleeding/Hematoma between groups
- Examine the difference in hospital length of stay between groups
- Examine renal function post procedure
- Difference in pain or numbness in the distal extremity between groups
- Mortality related to complications from vascular closure site between groups
- Conversion to general anesthesia due to additional procedures required to address the CFA access site complications between groups
- Conditions
- Aortic Stenosis
- Being tested
- Shockwave M5 IVL Catheter, Modified Seldinger Technique
- Keywords
- Aortic Stenosis, Transcatheter aortic valve replacement
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shockwave M5 IVL CatheterDevice
The Shockwave M5 IVL Catheter is a balloon catheter designed to modify calcified arterial plaque using intravascular lithotripsy prior to vascular access
Modified Seldinger TechniqueProcedure or surgery
Standard of care for femoral access in patients with calcified femoral arteries
Modified Seldinger TechniqueProcedure or surgery
Standard femoral artery access using the modified Seldinger technique without any prior vessel preparation or plaque modification.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Modified Seldinger Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate for contrast extravasation post closure of femoral artery at the end of the procedure
Measured: Immediately post-procedure
Secondary outcomes (15)
Determine need for Vascular surgery consultation
Measured: During hospital stay (Day 0-3)
If vascular complication, was PTA, stenting, or open surgery used
Measured: During hospital stay (Day 0-3)
Number of perclose devices used to close the femoral artery access site
Measured: During procedure (Day 0)
Determine presence of other vascular complications I.e. bleeding, hematoma, emboli etc
Measured: Within 3 days post-procedure
Change in Hemoglobin
As part of evaluating clinical deterioration, this outcome measures the drop in hemoglobin (g/dL)
Measured: Day 0 to Day 3 post-procedure
Change in Serum Creatinine
As part of evaluating clinical deterioration, this outcome assesses the increase in serum creatinine (mg/dL)
Measured: Day 0 to Day 3 post procedure
Incidence of Hypotension or Shock
As part of evaluating clinical deterioration, this outcome captures the number of participants who develop hypotension (SBP < 90 mmHg) or clinical shock.
Measured: Day 0 to Day 3 post-procedure
Incidence of Infections or Sepsis
As part of evaluating clinical deterioration, this outcome records the number of participants diagnosed with infection or sepsis
Measured: Day 0 to Day 3 post-procedure
Determine if there is a difference between hospital length of stay
Hospital length of stay will be measured in days from the date of admission to the date of discharge. The total duration will be compared between the intervention and control groups.
Measured: From date of admission to date of discharge, assessed up to 60 days
Assess for difference in pain/numbness in distal extremities post-procedure (Yes/No)
Measured: Within 3 days post-procedure
Assess for differences in mortality related to complications between the groups
Presence of new or worsening pain or numbness in the distal extremities will be assessed by patient-reported symptoms during routine clinical evaluation and physical examination. If present, symptoms will be documented in medical records
Measured: Up to 3 months post-procedure
Failure of treatment
Failure to achieve the intended procedural outcomes or additional interventions due to complications
Measured: Day 0 to discharge (or up to 3 days post-procedure)
Number of related AE(s)
Measured: Up to 3 months post-procedure
Number of related SAE(S)
Measured: Up to 3 months post-procedure
Side effects reported by subjects or observed by study team
Measured: Within 3 days post-procedure, or up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start4 Oct 2025
- Primary completion4 Oct 2028 (estimated)
- Study completion4 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shockwave Medical, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205068
- Sponsor's protocol ID
- 5319
- Other IDs
- Institutional Review Board
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure
- ClinicalTrials.gov ID
- NCT07205068
- Acronym / sponsor ID
- 5319
- Conditions
- Aortic Stenosis
- Keywords
- Aortic Stenosis, Transcatheter aortic valve replacement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Tennessee Graduate School of MedicineUniversity, hospital or other
- Collaborators
- Shockwave Medical, Inc.
- Study start
- 4 Oct 2025 (actual)
- Primary completion
- 4 Oct 2028 (estimated)
- Study completion
- 4 Oct 2028 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine the clinical outcomes between groups
- Distinguish extravasation post closure at the end of the procedure
- Compare the need for open vascular surgery between groups
- Examine PTA or Stents to the CFA to help hemostasis or local vascular complications between groups
- Number of Perclose devices used between groups
- Compare Bleeding/Hematoma between groups
- Examine the difference in hospital length of stay between groups
- Examine renal function post procedure
- Difference in pain or numbness in the distal extremity between groups
- Mortality related to complications from vascular closure site between groups
- Conversion to general anesthesia due to additional procedures required to address the CFA access site complications between groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shockwave model (M5) Intravascular Lithotripsy (IVL) | Experimental | Device: Shockwave M5 IVL Catheter, Procedure: Modified Seldinger TechniquePatients will be treated with the Shockwave M5 Intravascular Lithotripsy (IVL) device prior to femoral artery access using the modified Seldinger technique |
| Standard femoral access | Active comparator | Procedure: Modified Seldinger TechniquePatients will receive standard femoral artery access via the modified Seldinger approach without utilizing intravascular lithotripsy in heavily calcified femoral arteries |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shockwave M5 IVL CatheterThe Shockwave M5 IVL Catheter is a balloon catheter designed to modify calcified arterial plaque using intravascular lithotripsy prior to vascular access | Device | Shockwave model (M5) Intravascular Lithotripsy (IVL) |
| Modified Seldinger TechniqueStandard of care for femoral access in patients with calcified femoral arteries | Procedure or surgery | Shockwave model (M5) Intravascular Lithotripsy (IVL) |
| Modified Seldinger TechniqueStandard femoral artery access using the modified Seldinger technique without any prior vessel preparation or plaque modification. | Procedure or surgery | Standard femoral access |
Primary outcome
Evaluate for contrast extravasation post closure of femoral artery at the end of the procedure
Time frame: Immediately post-procedure
15 secondary outcomes
Determine need for Vascular surgery consultation
Time frame: During hospital stay (Day 0-3)
If vascular complication, was PTA, stenting, or open surgery used
Time frame: During hospital stay (Day 0-3)
Number of perclose devices used to close the femoral artery access site
Time frame: During procedure (Day 0)
Determine presence of other vascular complications I.e. bleeding, hematoma, emboli etc
Time frame: Within 3 days post-procedure
Change in Hemoglobin
Time frame: Day 0 to Day 3 post-procedure
Change in Serum Creatinine
Time frame: Day 0 to Day 3 post procedure
Incidence of Hypotension or Shock
Time frame: Day 0 to Day 3 post-procedure
Incidence of Infections or Sepsis
Time frame: Day 0 to Day 3 post-procedure
Determine if there is a difference between hospital length of stay
Time frame: From date of admission to date of discharge, assessed up to 60 days
Assess for difference in pain/numbness in distal extremities post-procedure (Yes/No)
Time frame: Within 3 days post-procedure
Assess for differences in mortality related to complications between the groups
Time frame: Up to 3 months post-procedure
Failure of treatment
Time frame: Day 0 to discharge (or up to 3 days post-procedure)
Number of related AE(s)
Time frame: Up to 3 months post-procedure
Number of related SAE(S)
Time frame: Up to 3 months post-procedure
Side effects reported by subjects or observed by study team
Time frame: Within 3 days post-procedure, or up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shockwave M5 IVL Catheter and Modified Seldinger Technique in people with Aortic Stenosis, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate for contrast extravasation post closure of femoral artery at the end of the procedure (time frame: Immediately post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.