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).
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.
Study Type
OBSERVATIONAL
Enrollment
21
Asan Medical Center
Seoul, South Korea
The Catholic University of Korea Eunpyeong St. Mary's Hospital
Seoul, South Korea
Clinical Success Criteria
If the residual stenosis rate of the lesion is less than 30% after completion of percutaneous coronary intervention using an investigational device If major adverse cardiovascular events (MACE)† have not occurred within 48 hours after the procedure or the time of discharge, whichever comes first
Time frame: 48hours
Technical Success Criteria
The stent (or balloon catheter) has successfully reached the target lesion without switching to manual manipulation
Time frame: 48hours
Effective dose(mSv)
The effective dose (mSv) is calculated as follows by multiplying the dose-length product (Dose-length product, DLP, mGy.cm) measured by the dosimeter on the chest of the subject and the operator and the weighting factor for each tissue
Time frame: 48hours
Procedure time (min)
\- It is defined as the time from the manipulation of the guidewire using the investigational device to the removal of the guidewire. Total procedure time(min) \- It is defined as the time from insertion of the arterial sheath to the point of removal of the sheath.
Time frame: 48hours
TEAE
treatment emergent adverse event, TEAE
Time frame: 1month
MACE
Major Adverse Cardiovascular Events) occurring in the study subjects during the clinical trial period.
Time frame: 1month
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