NCT05862558 · Baylor Research Institute
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
(ILIT)
What this study is about
To assess the effectiveness and safety of Intravascular Lithotripsy (IVL) in subjects undergoing transfemoral TAVR in patients with severe iliac disease, prohibitive for transfemoral TAVR in patients with severe symptomatic aortic stenosis, otherwise considered for alternative access TAVR. (e.g.
View original scientific description
To assess the efficacy and safety of Intravascular Lithotripsy (IVL) in subjects undergoing transfemoral TAVR in patients with severe iliac disease, prohibitive for transfemoral TAVR in patients with severe symptomatic aortic stenosis, otherwise considered for alternative access TAVR. (e.g.
Interventions
DEVICE
Shockwave Balloon
Intravascular lithotripsy (IVL) performed with the Shockwave balloon (Shockwave Medical Inc) enables treatment of calcified stenosis of the peripheral arteries by using sonic pressure waves to selectively disrupt superficial and deep calcium without impacting healthy tissue
Primary outcome measures
Acute technical success per the DISRUPT PAD definition at the time of intervention
Time frame: At time of IVL procedure
Defined as final residual stenosis ≤30% without flow-limiting dissection (≥ Grade D) of the lesion
Success rate of transfemoral delivery of a TAVR system post IVL within 30 days of treatment
Time frame: At the time of TAVR procedure
To know the efficacy of the treatment
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
- Age 18 to 90 years of age, inclusive, at the time of signing the informed consent
- Iliofemoral disease warrants treatment, per routine guidelines (greater than 50% stenosis and heavy calcification of the iliac's).
- Severe symptomatic aortic stenosis and undergoing a planned TAVR procedure
- Prohibitive iliofemoral disease, as determined by the diagnostic CT abdomen and pelvis.
- Subjects can provide written, informed consent.
Exclusion criteria
- Subject is participating in another research study involving an investigational agent that has not reached the primary endpoint.
- Subject who has contraindications to IVL
- Subject who has contraindications or is not eligible for TAVR
Where
- Plano, Texas
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 Jan 13, 2026 · Source of record for eligibility and locations