Status:
COMPLETED
AVIAR(MX-02) Robotic-assisted Percutaneous Coronary Intervention
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
LN Robotics
Conditions:
Percutaneous Coronary Intervention
Eligibility:
All Genders
19+ years
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 percutane...
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 pr...
Eligibility Criteria
Inclusion
- General
- 1\. Adult women and men who are aged ≥19 and \<75 years 2. Those who are suspected of stable angina and need percutaneous coronary intervention 3. Those who voluntarily decided to participate in this clinical trial and agreed in writing to the informed consent form 4. Those who are willing to comply with the protocol
- Angiographic
- If the lesion to be treated by coronary angiography (target lesion) is a native coronary artery lesion that has not been previously treated
- If the diameter of the lesioned vessel to be treated by coronary angiography (target vessel) is between 2.5 mm and 4.5 mm (by visual estimate).
- If diameter stenosis of the target vessel ≥50% (by visual estimate)
Exclusion
- General
Key Trial Info
Start Date :
October 16 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 26 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05981859
Start Date
October 16 2023
End Date
April 26 2024
Last Update
July 17 2024
Active Locations (2)
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1
Asan Medical Center
Seoul, South Korea
2
The Catholic University of Korea Eunpyeong St. Mary's Hospital
Seoul, South Korea