Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
Study NCT ID:
NCT06974760
Status:
COMPLETED
Last Update Posted:
2025-07-31
First Post:
2025-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Multicenter, Blinded, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of IVUS Console and IVUS Catheter in Coronary Intervention Procedures
Sponsor:
Pulse Medical Imaging Technology (Shanghai) Co., Ltd
Organization:
Study Overview
Official Title:
A Prospective, Multicenter, Blinded, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of IVUS Console and IVUS Catheter in Coronary Intervention Procedures
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IVUS
Brief Summary:
The goal of this clinical trial is to evaluate the safety and efficacy of IVUS Console and IVUS Catheter in coronary intervention therapy
Participants will:
Undergo IVUS examinations from two different manufacturers（from Pulse and Boston Scientific）
Participants will:
Undergo IVUS examinations from two different manufacturers（from Pulse and Boston Scientific）
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: