Comparison of Safety and Efficacy Between the Robot-assisted System AVIAR (MX-02) Procedure and C… (NCT06735716) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comparison of Safety and Efficacy Between the Robot-assisted System AVIAR (MX-02) Procedure and Conventional Manual Procedure in Patients Requiring Percutaneous Coronary Intervention
South Korea80 participantsStarted 2025-03-10
Plain-language 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)
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. If diameter stenosis of the target vessel ≥50% (by visual estimate)
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)