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NCT03521804 · ClinicalTrials.gov registry record · NA
Safety and Efficacy Study of the SoundBite™ Crossing System With ACTIVE Wire in Coronary CTOs.
A NA study, sponsored by SoundBite Medical Solutions.
- Terminated
- Registry status
- NA
- Development phase
- 35
- Enrollment target
NCT03521804: Clinical Trial NA study, sponsored by SoundBite Medical Solutions.
NCT03521804 is a NA study that was terminated before completion, run by SoundBite Medical Solutions. The registered enrollment target is 35 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03521804, a NA study, was terminated before completion, sponsored by SoundBite Medical Solutions.
- TERMINATED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
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).
Primary Outcome
Device Success defined as: Successful antegrade crossing of the CTO into the true arterial lumen distal to the occlusion following advancement of at least 3 mm of the Soundbite(TM) Crossing System into any segment as assessed by the core angiographic laboratory. An antegrade only approach may involve Antegrade Dissection Re-Entry (ADR) with or without the use of specialized devices (e.g. Stingray); absence of successful retrograde crossing of a collateral will still be considered an antegrade on
Interventions
- DEVICE SoundBite™ Crossing System Active Wire 14
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2018-06-21 |
| Est. Completion | 2020-11-20 |
| Phase | NA |
Why NCT03521804 stopped before completion
NCT03521804 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which SoundBite™ Crossing System Active Wire 14 is the first listed.
NCT03521804 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03521804 about?
NCT03521804 is a clinical study titled "Safety and Efficacy Study of the SoundBite™ Crossing System With ACTIVE Wire in Coronary CTOs.". 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).
What is the current status of trial NCT03521804?
This trial is currently terminated. It is a NA study. The enrollment target is 35 participants. The study started on 2018-06-21. Estimated completion is 2020-11-20.
What interventions are being tested in trial NCT03521804?
The interventions under investigation include: SoundBite™ Crossing System Active Wire 14 (DEVICE).
Who is sponsoring clinical trial NCT03521804?
This trial is sponsored by SoundBite Medical Solutions, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03521804's enrollment target sits among peer trials
35 1564th of 2000 higher than 431 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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