NCT05862558 Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
| NCT ID | NCT05862558 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baylor Research Institute |
| Condition | Iliac Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-03-30 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2023-03-30 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. trans-carotid)
Eligibility Criteria
Inclusion Criteria: 1. Age 18 to 90 years of age, inclusive, at the time of signing the informed consent 2. Iliofemoral disease warrants treatment, per routine guidelines (greater than 50% stenosis and heavy calcification of the iliac's). 3. Severe symptomatic aortic stenosis and undergoing a planned TAVR procedure 4. Prohibitive iliofemoral disease, as determined by the diagnostic CT abdomen and pelvis. 5. Subjects can provide written, informed consent. Exclusion Criteria: 1. Subject is participating in another research study involving an investigational agent that has not reached the primary endpoint. 2. Subject who has contraindications to IVL 3. Subject who has contraindications or is not eligible for TAVR
Frequently Asked Questions
Who can join the NCT05862558 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Iliac Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05862558 currently recruiting?
Yes, NCT05862558 is actively recruiting participants. Visit ClinicalTrials.gov or contact Baylor Research Institute to inquire about joining.
Where is the NCT05862558 trial being conducted?
This trial is being conducted at Plano, United States.
Who is sponsoring the NCT05862558 clinical trial?
NCT05862558 is sponsored by Baylor Research Institute. The trial plans to enroll 50 participants.