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Robots take on heart surgery: safer for doctors?

NCT ID NCT06735716

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study compares a robot-assisted heart procedure to the standard manual approach in 80 adults with stable angina who need a stent. The robot, called AVIAR, helps guide catheters and balloons. Researchers will check if the robot is as safe and effective, and if it reduces radiation exposure for the doctor.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
robot-assisted procedure using AVIAR (MX-02) positioning catheter control device
What this could lead to
If successful, this could show that robot-assisted heart procedures are as safe and effective as manual ones, with less radiation exposure for doctors.
What could go wrong
This is a small, early-stage study with only 80 participants, so results may not apply to all patients. The robot may not work as well in complex cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Target number of participants for this clinical trial is a total of 80 patients during study duration . If subjects who meet the "Coronary Angiography Selection/Exclusion Criteria" are eligible to be enrolled in the clinical trial. These subjects will undergo the standard pre-procedural preparations and receive local anesthesia on the day of the procedure. 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.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 Exclusion Criteria 1. Those with a left ventricular ejection fraction (LVEF) ≤ 30% 2. Those who have a history of hypersensitivity to contrast agents such as stainless steel, cobalt-chromium, etc. 3. Those who cannot stop taking antithrombotic drugs (anticoagulants, antiplatelet drugs) 4. Those diagnosed with thrombocytopenia, thrombocytosis, neutropenia, or leukopenia 5. Those who have a history of bleeding diathesis or coagulopathy or who refuse transfusion 6. Those with a history of stroke (CVA) or transient ischemic attack (TIA) within 4 weeks from the screening date 7. .Those with a history of active peptic ulcer or upper gastrointestinal bleeding within 24 weeks from the screening date 8. Those with ST-elevation myocardial infarction (STEMI) (for example, those who started myocardial infarction symptoms within 72 hours from the screening date) 9. Those with a history of cardiogenic shock or cardiac arrest 10. Those who underwent coronary artery bypass grafting (CABG) 11. Those who underwent percutaneous coronary intervention (PCI) within 72 hours from the screening date 12. Those who had a major adverse coronary event (MACE) or a serious adverse event (SAE) after receiving the percutaneous coronary intervention (PCI) within 4 weeks from the screening date 13. Those who are scheduled to undergo percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 4 weeks from the end of this clinical trial 14. Those diagnosed with renal failure or those who are not suitable for angiography due to severe renal dysfunction (creatine \>2.0 mg/dL or eGFR (estimated glomerular filtration rate) \<30 ml/min) within one week prior to the date of coronary angiography 15. Pregnant and breastfeeding women 16. Women of childbearing potential who plan to become pregnant during this clinical trial 17. A woman\* or spouse who is likely to be pregnant does not agree to use contraception in medically acceptable method of contraception\*\* during the clinical trial 18. Those who are currently participating in other clinical trials or have experience participating in other clinical trials within 12 weeks from the screening date.However, where at least one or more conditions are satisfied, it could be an exception according to an investigator's discretion * Participated in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial * Screening failed before any interventional factor is involved-Participated in academic trials like strategic or medical device comparison 19. Other cases where the investigator determines that participation in a clinical trial is inappropriate ethically or because it may affect the study outcome. * Angiographic Exclusion Criteria 1\. Those who require manual or mechanical thrombectomy, rotational atherectomy, directional coronary atherectomy (DCA), etc. in addition to stent placement and balloon dilatation 2. When the two-stent technique is required for the side branch of the target bifurcation lesion. 3\. When the investigator determines that PCI is not suitable because the target lesion hasany of the following characteristics: ①he target lesion is a chronic total occlusion (CTO) or total occlusion ②An ostial lesion in location ③The target vessel has evidence of intraluminal thrombus ④Moderate or severe calcification at the target lesion or near the target lesion ⑤If PCI cannot be performed for other reasons 4. If the investigator determines that the subject is not suitable for robotic-assisted PCI due to clinical and anatomical reasons.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, South Korea

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    Seoul, South Korea

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