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Prospective Study of the SoundBite™ Crossing System in Complex Peripheral CTOs

NCT03933657 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-09-14

No results posted yet for this study

Summary

This study aims at assessing additional performance characteristics of the SoundBite™ Crossing System with regards to the luminal passage of complex Chronic Total Occlusions (CTO) by evaluating clinically relevant efficacy, safety, cost benefit and treatment pathway endpoints.

Conditions

  • Peripheral Arterial Occlusive Disease
  • Chronic Total Occlusion of Artery of the Extremities

Interventions

DEVICE

SoundBite™ Crossing System - Peripheral

SoundBite™ Crossing System consisting of the SoundBite™ Console and SoundBite™ Active Wire 18. The Investigator may use the SoundBite™ Active Wire during the procedure to cross the proximal aspect and/or to cross multiple lesions.

Sponsors & Collaborators

  • ethica Clinical Research Inc.

    collaborator INDUSTRY

  • Montreal Heart Institute

    collaborator OTHER

  • SoundBite Medical Solutions, Inc.

    lead INDUSTRY

Principal Investigators

  • George Adams, MD · Rex Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-30
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • Austria
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03933657 on ClinicalTrials.gov