Ignite Creation Date:
2024-05-06 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03521804
Status:
TERMINATED
Last Update Posted:
2023-12-06
First Post:
2018-04-30
Brief Title:
Safety and Efficacy Study of the SoundBite Crossing System With ACTIVE Wire in Coronary CTOs
Sponsor:
SoundBite Medical Solutions Inc
Organization:
SoundBite Medical Solutions Inc
Study Overview
Official Title:
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
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACTIVE
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None