AVIAR(MX-02) Robotic-assisted Percutaneous Coronary Intervention

NCT05981859 | Completed DMC

• 1 other identifier: 2023-0838
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this study is to evaluate the safety and efficacy of the steerable catheter control system 'AVIAR(MX-02)', which remotely controls the guidewire and stent/balloon during the percutaneous coronary intervention (PCI) for those who have suspected coronary artery disease (CAD) and need PCI (for product approval from the MFDS).

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

• Effective dose(mSv)

  The effective dose (mSv) is calculated as follows by multiplying the dose-length product (Dose-length product, DLP, mGy.cm) measured by the dosimeter on the chest of the subject and the operator and the weighting factor for each tissue

  48hours

• Procedure time (min)

  \- It is defined as the time from the manipulation of the guidewire using the investigational device to the removal of the guidewire. Total procedure time(min) \- It is defined as the time from insertion of the arterial sheath to the point of removal of the sheath.

  48hours

Secondary Outcomes (2)

• TEAE

  1month

• MACE

  1month

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 20 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. The angiography will be performed using the investigational medical device "AVIAR (MX-02)" via a percutaneous coronary intervention procedure.

You may qualify if:

• \. Adult women and men who are aged ≥19 and \<75 years 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
• 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
• LN Robotics: 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

Related Publications (1)

• Lee J, Kim TO, Lee PH, Kim YH, Kwon O, Lee SW. Safety and Feasibility of Robot-Assisted Percutaneous Coronary Intervention Using the AVIAR 2.0 System: A Prospective, Multi-Center, Single-Arm, Open, Investigator-Initiated, Post-Approval Clinical Trial. Korean Circ J. 2025 Apr;55(4):325-335. doi: 10.4070/kcj.2024.0226. Epub 2024 Nov 5.

  PMID: 39733457 DERIVED

Study Officials

• Seung-Whan Lee, MD

  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: Principle Investigator

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 8, 2023
• Study Start: October 16, 2023
• Primary Completion: March 25, 2024
• Study Completion: April 26, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

KR (2)