Safety and Efficacy Study of the SoundBite™ Crossing System With ACTIVE Wire in Coronary CTOs. (NCT03521804) | Clinical Trial Compass
TerminatedNot Applicable
Safety and Efficacy Study of the SoundBite™ Crossing System With ACTIVE Wire in Coronary CTOs.
Stopped: Business decision
United States, Canada35 participantsStarted 2018-06-21
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject planned to undergo clinically driven percutaneous coronary intervention (PCI) targeting a single CTO. Clinical justification of a CTO PCI includes anginal symptoms, dyspnea or left ventricular dysfunction presumed or documented to be the result of ischemia in the CTO territory.
. PCI procedure is planned to be performed with a wire based antegrade primary strategy.
. Subject is ≥ 18 years old.
. Subject is able and willing to provide written informed consent prior to study procedure.
. Target CTO is in a native coronary artery and demonstrates TIMI flow grade 0.
. Target CTO is presumed documented angiographically to be greater than 3 months old.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Device success
Timeframe: Day 1
2
Freedom from the composite SoundBite™ Crossing System related MAEs
. Target CTO length is visually estimated to be ≥ 5mm.
. Target reference vessel diameter ≥ 2.5mm.
Exclusion criteria
. Life expectancy \< 1 year.
. Hypersensitivity or contraindication to aspirin, P2Y12 platelet receptor inhibitors, heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available.
. Target occlusion has an iatrogenic dissection that occurred within the past 3 months.
. Subject has received ≥5 Gy exposure to the chest within 3 months.
. Subject has known elevated cardiac biomarkers (CK-MB or cTn) within 30 days prior to index procedure.
. Left ventricular ejection fraction less than 20%.
. Severe aortic or mitral valve disease.
. Planned left ventricular (LV) support device during CTO PCI.