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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 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.

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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)

Interventions

  • DEVICE Shockwave Balloon

Study Locations (1)

Texas

  • Baylor Scott and White Heart Hospital - Plano

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2023-03-30
Est. Completion 2026-06-01

Sponsor

Baylor Research Institute

180 total trials

What the Registry Record Tells You About NCT05862558

The ClinicalTrials.gov registry entry for NCT05862558 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,042-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (95% lower). The listed sponsor is Baylor Research Institute, which has 180 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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