Comparison of Procedural and Clinical Outcomes Between Robot Assisted and Conventional Manual Approaches in Patients With Coronary Artery Disease Requiring Percutaneous Coronary Intervention
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Percutaneous Coronary Intervention
- Sponsor
- Asan Medical Center
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Clinical Success Criteria
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Tae Oh Kim
Principal Investigator
Asan Medical Center
Eligibility Criteria
Inclusion Criteria
- •\* General Inclusion Criteria
- •Adult women and men who are aged ≥19
- •Those who are suspected of stable angina and need percutaneous coronary intervention
- •Those who voluntarily decided to participate in this clinical trial and agreed in writing to the informed consent form
- •Those who are willing to comply with the protocol.
- •\* Angiographic Inclusion Criteria
- •If the target lesion is a single lesion.
- •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 Criteria
- •\* General Exclusion Criteria
- •Those with a left ventricular ejection fraction (LVEF) ≤ 30%
- •Those who have a history of hypersensitivity to contrast agents such as stainless steel, cobalt-chromium, etc.
- •Those who cannot stop taking antithrombotic drugs (anticoagulants, antiplatelet drugs)
- •Those diagnosed with thrombocytopenia, thrombocytosis, neutropenia, or leukopenia
- •Those who have a history of bleeding diathesis or coagulopathy or who refuse transfusion
- •Those with a history of stroke (CVA) or transient ischemic attack (TIA) within 4 weeks from the screening date
- •.Those with a history of active peptic ulcer or upper gastrointestinal bleeding within 24 weeks from the screening date
- •Those with ST-elevation myocardial infarction (STEMI) (for example, those who started myocardial infarction symptoms within 72 hours from the screening date)
- •Those with a history of cardiogenic shock or cardiac arrest
Outcomes
Primary Outcomes
Clinical Success Criteria
Time Frame: 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
Time Frame: 48hours
The stent (or balloon catheter) has successfully reached the target lesion without switching to manual manipulation.
Radiation exposure Patient
Time Frame: 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
Time Frame: 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 Outcomes
- TEAE(1month)
- MACE(1month)