Percutaneous Coronary InterventionRoboticPCINCT06735716
Comparison of Safety and Efficacy Between the Robot-assisted System AVIAR (MX-02) Procedure and Conventional Manual Procedure in Patients Requiring Percutaneous Coronary Intervention
An observational study of Percutaneous Coronary Intervention, run by Asan Medical Center at 2 sites in South Korea.
Trial 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) Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention
- How many people
- 80 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 10 Mar 2025to 30 Jul 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- * 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
Show all 10Show fewer
- 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)
Who cannot join
- * 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
Show all 29Show fewer
- 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
- Those who underwent coronary artery bypass grafting (CABG)
- Those who underwent percutaneous coronary intervention (PCI) within 72 hours from the screening date
- 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
- 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
- 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
- Pregnant and breastfeeding women
- Women of childbearing potential who plan to become pregnant during this clinical trial
- 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
- 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.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Asan Medical Center
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul
About this study
Official title: Comparison of Procedural and Clinical Outcomes Between Robot Assisted and Conventional Manual Approaches in Patients With Coronary Artery Disease Requiring Percutaneous Coronary Intervention
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)
Read the 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.
- Conditions
- Percutaneous Coronary Intervention
- Keywords
- Robotic PCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A patient who received PCI procedure using a AVIAR. | 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. | |
| A patient who received PCI procedure wth conventional manual techniques. | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success Criteria
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
Measured: 48hours
Technical Success Criteria
The stent (or balloon catheter) has successfully reached the target lesion without switching to manual manipulation.
Measured: 48hours
Radiation exposure Patient
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.
Measured: 48hours
Radiation exposure Operator
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.
Measured: 48hours
Secondary outcomes (2)
TEAE
Treatment emergent adverse event, TEAE
Measured: 1month
MACE
Major Adverse Cardiovascular Events) occurring in the study subjects during the clinical trial period.
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start10 Mar 2025
- Primary completion5 Jun 2026
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- LNRobotics, inc.
- Responsible party
- Principal investigator, Tae Oh Kim, Asan Medical Center
- Investigators
- Tae-Oh kim, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735716
- Sponsor's protocol ID
- 2024-1271
- Acronym
- RoboticPCI
- Status last verified
- Jun 2026
- First submitted
- 9 Dec 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Procedural and Clinical Outcomes Between Robot Assisted and Conventional Manual Approaches in Patients With Coronary Artery Disease Requiring Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06735716
- Acronym / sponsor ID
- RoboticPCI / 2024-1271
- Conditions
- Percutaneous Coronary Intervention
- Keywords
- Robotic PCI
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- LNRobotics, inc.
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A patient who received PCI procedure using a AVIAR. | – | –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. |
| A patient who received PCI procedure wth conventional manual techniques. | – | –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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (10 listed)
- * General Inclusion Criteria
Key exclusion criteria (29 listed)
- * General Exclusion Criteria
- 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.
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
TEAE
Time frame: 1month
MACE
Time frame: 1month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
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RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
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ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tae-Oh kim principal investigator
Asan Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Coronary Intervention, run by Asan Medical Center at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success Criteria (time frame: 48hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.