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SoundBite Crossing System for Calcified Artery Blockages

This study is testing a device called the SoundBite Crossing System to treat chronic total occlusions (CTOs), which are complete blockages in arteries of your legs, especially when these blockages are calcified (hardened). The study aims to see how well the SoundBite Crossing System works and if it's safe to use. You might be able to join if you have a calcified CTO in your leg arteries and are scheduled for a procedure to treat it. The study will look at the device's performance and safety on the day of the procedure. The current recruitment status is unclear, and the study plans to enroll about 130 participants.

Study design
This is a prospective, multi-center, non-randomized, open-label study, meaning all participants will receive the SoundBite Crossing System, and both you and your doctors will know what treatment you are getting. Approximately 130 participants are planned for enrollment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary safety and performance of the device will be measured on the day of the procedure (Day 0).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05551780

Treatment of Calcific Total Occlusions in Peripheral Artery Disease

UNKNOWN
NAAges 19+InterventionalTreatment
SoundBite Medical Solutions, Inc.
~130 participants
Updated 2024-06-13 on ClinicalTrials.gov
What's tested:SoundBite Crossing System

At a glance

Recruiting sites
2 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Device Performance
Measured over Day 0
+1 more outcome measured

Conditions

Chronic Total Occlusion of Artery of the Extremities

Explore related trials

Chronic Total Occlusion VesselPeripheral Artery Disease

Where it's being run

5 sites across 5 states
Florida1
North Carolina1
Rhode Island1
Austria1
Germany1

Study leadership

  • George Adams, MD · PRINCIPAL_INVESTIGATOR · UNC REX Hospital, Raleigh, NC, USA
  • Michael Lichtenberg, MD · PRINCIPAL_INVESTIGATOR · Angiology Clinic and Vascular Centre, Arnsberg, Germany

Who to contact

John Schultz
[email protected]
514-312-9181
Email the study team

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What this trial measures

  • Device PerformanceDay 0

    Crossing of the lesion regardless of method or modality (e.g., antegrade or retrograde)

  • Device SafetyDay 0

    Procedural incidence of any of the following: no reflow, thrombus formation, abrupt closure, distal embolization, dissection or perforation requiring treatment