Percutaneous Coronary Intervention
Conditions
Keywords
Robotic PCI
Brief summary
The objective of this study is to compare and evaluate the safety and efficacy of robot-assisted procedures using the positioning catheter control device 'AVIAR (MX-02)' versus conventional manual procedures in patients with Stable angina requiring percutaneous coronary intervention (PCI)
Detailed description
A potential subject who meets the 'general inclusion/exclusion criteria' will be admitted before the procedure, undergo pre-procedure treatment according to the institution's standard procedures, and receive coronary angiography on the day of the procedure under local anesthesia. At this time, the investigator will review the 'coronary angiography inclusion/exclusion criteria', and only subjects who meet all the criteria will be enrolled in the clinical trial. After the subject is assigned a registration number, the robot-assisted procedure group will undergo percutaneous coronary intervention (PCI) using the clinical trial medical device 'AVIAR (MX-02)', while the conventional manual procedure group will undergo percutaneous coronary intervention (PCI) according to the standard 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. Please note that the above information is a general description of the procedure and criteria for the clinical trial involving percutaneous coronary intervention using the AVIAR (MX-02) device.
Interventions
None listed
Sponsors
Asan Medical Center
LNRobotics, inc.
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 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 5. If the target lesion is a single lesion. 6. If the lesion to be treated by coronary angiography (target lesion) is a native coronary artery lesion that has not been previously treated. 7. 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). 8. 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. |
| Radiation exposure Patient | 48hours | Patient Radiation exposure (Gy): The total procedure time is defined as the period from the insertion of the guidewire and guide catheter (introducer sheath) to their removal, during which the radiation exposure (DAP, Air Kerma) and fluoroscopy time are measured on the C-arm. |
| Radiation exposure Operator | 48hours | Operator radiation (mSv):It is verified by the radiation exposure measured using the personal electronic dosimeter worn by the operator on the chest and the radiation exposure measured on the procedure table. |
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
Contacts
PRINCIPAL_INVESTIGATORTae-Oh kim
Asan Medical Center
Outcome results
None listed