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NCT05862558 · ClinicalTrials.gov registry record
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
A clinical trial of Aortic Valve Stenosis and Iliac Disease, sponsored by Baylor Research Institute.
- Recruiting
- Registry status
- 50
- Enrollment target
- 1
- Study location
NCT05862558: Recruiting study of Aortic Valve Stenosis and Iliac Disease, sponsored by Baylor Research Institute.
NCT05862558 is a study of Aortic Valve Stenosis and Iliac Disease that is actively recruiting participants, run by Baylor Research Institute. The registered enrollment target is 50 participants, below the 1,042-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05862558, a study of Aortic Valve Stenosis and Iliac Disease, is actively recruiting participants, sponsored by Baylor Research Institute.
- RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 1
- Study location
Study 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)
Primary Outcome
Defined as final residual stenosis ≤30% without flow-limiting dissection (≥ Grade D) of the lesion
Conditions Studied
Interventions
- DEVICE Shockwave Balloon
Study Locations (1)
Texas
- Baylor Scott and White Heart Hospital - Plano
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-03-30 |
| Est. Completion | 2026-06-01 |
What NCT05862558 shows while recruiting
NCT05862558 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,042-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Aortic Valve Stenosis appearing as the primary indexed condition, and to 1 intervention - of which Shockwave Balloon is the first listed.
NCT05862558 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05862558 about?
NCT05862558 is a clinical study titled "Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR". 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-ca...
What is the current status of trial NCT05862558?
This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2023-03-30. Estimated completion is 2026-06-01.
What conditions does trial NCT05862558 study?
This clinical trial studies the following conditions: Aortic Valve Stenosis, Iliac Disease.
What interventions are being tested in trial NCT05862558?
The interventions under investigation include: Shockwave Balloon (DEVICE).
Who is sponsoring clinical trial NCT05862558?
This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05862558 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05862558's enrollment target sits among peer trials
50 25th of 30 higher than 6 of 30 other Aortic Valve Stenosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Valve Stenosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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