Comparison of Safety and Efficacy Between the Robot-assisted System AVIAR (MX-02) Procedure and Conventional Manual Procedure in Patients Requiring Percutaneous Coronary Intervention

NCT06735716 | Active Not Recruiting

• 1 other identifier: 2024-1271
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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)

Conditions

Percutaneous Coronary Intervention

Keywords

Robotic PCI

Outcome Measures

Primary Outcomes (4)

• 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

  48hours

• Technical Success Criteria

  The stent (or balloon catheter) has successfully reached the target lesion without switching to manual manipulation.

  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.

  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.

  48hours

Secondary Outcomes (2)

• TEAE

  1month

• MACE

  1month

Study Arms (2)

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).
• If diameter stenosis of the target vessel ≥50% (by visual estimate)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• LNRobotics, inc.: collaborator

Study Sites (2)

Asan Medical Center

Seoul, South Korea

Location

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

Seoul, South Korea

Location

Study Officials

• Tae-Oh kim

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 16, 2024
• Study Start: March 10, 2025
• Primary Completion: June 5, 2026
• Study Completion: July 30, 2026
• Last Updated: June 25, 2026

Record last verified: 2026-06

Locations

KR (2)