Treatment of Calcific Total Occlusions in Peripheral Artery Disease

Part of paid clinical trials in Fort Lauderdale, Florida.

Sponsor
SoundBite Medical Solutions, Inc.
Study ID
NCT05551780
Status
Recruiting
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Conditions

  • Chronic Total Occlusion of Artery of the Extremities

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SoundBite Crossing System — DEVICE
    Use of the SoundBite Crossing System to cross calcified chronic total occlusions

Study Details

Prospective, multi-center, non-randomized, open label, clinical study intended to provide data to demonstrate safety and performance of the SoundBite Crossing System XS Peripheral.

Key Dates

Start date
Feb 21, 2023
Status verified
Jun 2024
Primary completion
Nov 30, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
130 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SoundBite Crossing System - PAD
    Use of the SoundBite Crossing System to cross calcified chronic total occlusions (above-the-knee or below-the-knee)
  • Experimental: SoundBite Crossing System - BTK
    Use of the SoundBite Crossing System to cross calcified chronic total occlusions (below-the-knee)

Primary Outcome Measure

Device Performance [ Time Frame: Day 0 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Palm Vascular CentersFort LauderdaleFlorida33312
Jennifer Gimeno
[email protected]
UNC REX HospialRaleighNorth Carolina27607
Rebecca Palermo
[email protected]
Lifespan - The Miriam HospitalProvidenceRhode Island02906

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By research site
Palm Vascular Centers· Fort Lauderdale, FLUNC REX Hospial· Raleigh, NCLifespan - The Miriam Hospital· Providence, RI

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