Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-29 @ 5:51 PM
Study NCT ID:
NCT05981859
Status:
COMPLETED
Last Update Posted:
2024-07-17
First Post:
2023-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AVIAR(MX-02) Robotic-assisted Percutaneous Coronary Intervention
Sponsor:
Asan Medical Center
Organization:
Study Overview
Official Title:
Safety and Efficacy of PCI Cardiac Mapping System Workstation 'AVIAR (MX-02)' in Patients Undergoing Percutaneous Coronary Intervention (PCI): Prospective, Multi-center, Single-arm, Open, Post-approval Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-07
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:
RoboticPCI
Brief Summary:
The objective of this study is to evaluate the safety and efficacy of the steerable catheter control system 'AVIAR(MX-02)', which remotely controls the guidewire and stent/balloon during the percutaneous coronary intervention (PCI) for those who have suspected coronary artery disease (CAD) and need PCI (for product approval from the MFDS).
Detailed Description:
The potential subjects who meet the "Coronary Angiography Selection/Exclusion Criteria" are eligible to be enrolled in the clinical trial. These individuals will undergo the standard pre-procedural preparations and receive local anesthesia on the day of the procedure. The angiography will be performed using the investigational medical device "AVIAR (MX-02)" via a percutaneous coronary intervention procedure. After the procedure, the subjects will remain in a supine position for approximately 4 hours in the recovery room or hospital room to ensure absolute stability. During this time, the investigator will observe the puncture site for hemostasis and monitor for any adverse events.
Within 2 days after the procedure or prior to discharge, the subjects will undergo safety assessments and evaluations for the occurrence of any adverse events or serious adverse events. Additionally, at the 1-month follow-up, all required follow-up tests will be completed, and if no adverse events have occurred or if any previously occurring adverse events have been resolved, the clinical trial for that particular subject will be concluded. However, if any adverse events remain unresolved and are deemed unrelated to the clinical trial by the investigator, the trial may be terminated for that subject.
Within 2 days after the procedure or prior to discharge, the subjects will undergo safety assessments and evaluations for the occurrence of any adverse events or serious adverse events. Additionally, at the 1-month follow-up, all required follow-up tests will be completed, and if no adverse events have occurred or if any previously occurring adverse events have been resolved, the clinical trial for that particular subject will be concluded. However, if any adverse events remain unresolved and are deemed unrelated to the clinical trial by the investigator, the trial may be terminated for that subject.
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?:
None
Is an FDA AA801 Violation?: