Percutaneous Coronary Intervention
Conditions
Keywords
Robotic PCI
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.
Interventions
None listed
Sponsors
LN Robotics
Asan Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* General Inclusion Criteria: 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 Inclusion Criteria: 1. If the lesion to be treated by coronary angiography (target lesion) is a native coronary artery lesion that has not been previously treated 2. 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). 3. If diameter stenosis of the target vessel ≥50% (by visual estimate)
Exclusion criteria
* General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success Criteria | 48hours | 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 |
| Technical Success Criteria | 48hours | The stent (or balloon catheter) has successfully reached the target lesion without switching to manual manipulation |
| Effective dose(mSv) | 48hours | 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 |
| Procedure time (min) | 48hours | \- 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TEAE | 1month | treatment emergent adverse event, TEAE |
| MACE | 1month | Major Adverse Cardiovascular Events) occurring in the study subjects during the clinical trial period. |
Countries
South Korea
Outcome results
None listed