A Single-Arm Study to Assess the Safety and Efficacy of the SoundBite™ Crossing System With ACTIVE Wire in Coronary Chronic Total Occlusions (the ACTIVE Trial).
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic Total Occlusion of Coronary Artery
- Sponsor
- SoundBite Medical Solutions, Inc.
- Enrollment
- 35
- Locations
- 5
- Primary Endpoint
- Device success
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Device success
Time Frame: 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
Time Frame: 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 Outcomes
- Overall Device Success(Day 1)
- Procedural Success(Day 1)
- Freedom from SoundBite™ Crossing System related MAE(30 days post-procedure)
- Technical Success(Day 1)
- Clinical Success:(30 days post-procedure)