Safety and Efficacy Study of the SoundBite™ Crossing System With ACTIVE Wire in Coronary CTOs.
- Conditions
- Chronic Total Occlusion of Coronary Artery
- Interventions
- Device: SoundBite™ Crossing System Active Wire 14
- Registration Number
- NCT03521804
- Lead Sponsor
- SoundBite Medical Solutions, Inc.
- Brief 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).
- Detailed Description
The study is intended to demonstrate that the SoundBite™ Crossing System - Coronary can facilitate the passage of either 1) devices intended to treat a CTO or 2) guidewires or additional crossing devices into the true lumen distal to the CTO.
SoundBite™ Crossing System - Coronary, which consists of a re-usable console and a disposable device (ACTIVE Wire).
The SoundBite™ Crossing System - Coronary is intended to facilitate passage of a guidewire or therapeutic devices through a coronary artery Chronic Total Occlusion.
This is a prospective, multi-center, multinational, single-arm, phased clinical study intended to provide pivotal data for device approval.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SoundBite™ Crossing System-Coronary SoundBite™ Crossing System Active Wire 14 Crossing of coronary chronic total occlusions.
- Primary Outcome Measures
Name Time Method Device success Day 1 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 only approach.
Freedom from the composite SoundBite™ Crossing System related MAEs 48 hours or until discharge Freedom from the composite SoundBite™ Crossing System related major adverse events (MAEs) at 48 hours or hospital discharge (whichever occurs first) post procedure, as per Clinical Events Committee (CEC) adjudication, defined as:
* Cardiovascular related deaths
* Myocardial Infarction (Primary definition of clinically relevant post procedure MI from SCAI (1).
* Coronary Artery Perforation requiring treatment
* Unscheduled cardiac surgery anytime between enrollment to completion of the study.
* Intra-procedure stroke
* Radiation exposure ≥ 8 Gy
- Secondary Outcome Measures
Name Time Method Overall Device Success Day 1 Successful crossing of the CTO, following use of the SoundBite™ Crossing Wire during the procedure including antegrade or retrograde approach.
Freedom from SoundBite™ Crossing System related MAE 30 days post-procedure Freedom from SoundBite™ Crossing System related MAE assessed through 30 days post-index procedure, per CEC adjudication. Secondary MAE analysis employing the Third Universal consensus definition of Myocardial Infarction (MI)
Technical Success Day 1 Successful antegrade or retrograde crossing of the CTO into the true arterial lumen following advancement of at least 3 mm of the Soundbite Crossing System into the proximal segment as assessed by the core angiographic laboratory, with stent implantation and restoration of TIMI 3 flow, with less than 30% residual stenosis
Procedural Success Day 1 Achievement of Technical Success with freedom from In-Hospital device related MAEs per CEC adjudication.
Clinical Success: 30 days post-procedure Achievement of Procedural Success with freedom from device related MAEs through 48 hours or hospital discharge and 30 days post index procedure.
Trial Locations
- Locations (5)
Institut Universitaire de Cardiologie et de Pneumologie de Québec - IUCPQ
🇨🇦Québec, Quebec, Canada
Columbia University Medical Center/NYPH
🇺🇸New York, New York, United States
ICM - Institut de Cardiologie de Montreal
🇨🇦Montréal, Quebec, Canada
CHUM - Centre Hospitalier de l'Université de Montréal
🇨🇦Montréal, Quebec, Canada
MUHC- McGill University Health Centre
🇨🇦Montréal, Quebec, Canada