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Safety and Efficacy Study of the SoundBite™ Crossing System With ACTIVE Wire in Coronary CTOs.

NCT03521804 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-12-06

No results posted yet for this study

Summary

The objective of this study is to evaluate the safety and efficacy of the SoundBite™ Crossing System - Coronary (SCS-C) in a subject population with chronic coronary artery disease including Chronic Total Occlusion (CTO).

Conditions

  • Chronic Total Occlusion of Coronary Artery

Interventions

DEVICE

SoundBite™ Crossing System Active Wire 14

Successful crossing of the CTO into the true arterial lumen distal to the occlusion, following use of the SoundBite™ Crossing Wire during the procedure and using antegrade only approach. An antegrade only approach may involve Antegrade Dissection Re-Entry (ADR) with or without the use of specialized devices (i.e. Stingray). The absence of successful retrograde crossing of a collateral will still be considered an antegrade only approach.

Sponsors & Collaborators

  • ethica Clinical Research Inc.

    collaborator INDUSTRY

  • Cardiovascular Research Foundation, New York

    collaborator OTHER

  • SoundBite Medical Solutions, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-21
Primary Completion
2020-10-21
Completion
2020-11-20
FDA Device
Yes

Countries

  • United States
  • Canada

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 NCT03521804 on ClinicalTrials.gov