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Percutaneous Coronary InterventionRoboticPCINCT05981859

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

An observational study of Percutaneous Coronary Intervention, run by Asan Medical Center at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… 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
21 participants
Where
2 sitesSouth Korea
Study dates
16 Oct 2023to 26 Apr 2024
How long will I take part?
1 Month
Phase
Observational
Are there results?
None posted in the registry

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 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.

Who may be able to join

  • General Inclusion Criteria:
  • 1. 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
  • Angiographic Inclusion Criteria:
  • 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 33Show 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 a medically acceptable method of contraception** during the clinical trial
  • Pregnant women who have experienced first trimester (who have undergone surgical infertility (either uterine extraction or bilateral ovarian resection) or who have been defined as menopause for more than 12 months without any other reason are not women of childbearing age)
  • Hormonal contraception, vasectomy, intrauterine device (IUD) or IUS [intrauterine system], tubular ligation, double blocking (complex use of blocking methods such as condoms for men, condoms for women, cervical caps, contraceptive diaphragm, contraceptive sponge), and sanitizers a one-off method
  • Those who are currently participating in other clinical trials or have experience participating in other clinical trials within 12 weeks from the screening date
  • Other cases where the investigator determines that participation in a clinical trial is inappropriate ethically or because it may affect the study outcome.
  • ☞The specific reason is recorded in the CRF
  • Angiographic Exclusion Criteria:
  • Those who require manual or mechanical thrombectomy, rotational atherectomy, directional coronary atherectomy (DCA), etc. in addition to stent placement and balloon dilatation
  • If there are two or more target vessels
  • If there are two or more target lesions in one blood vessel
  • Any previous stent placement within 5 mm (proximal or distal) of the target lesion
  • When the investigator determines that PCI is not suitable because the target lesion hasany of the following characteristics:
  • Is severely tortuous ≥45°
  • An ostial lesion in location ③The target vessel has evidence of intraluminal thrombus or severe tortuosity (> 90°) proximal to the target lesion ④Moderate or severe calcification at the target lesion or near the target lesion ⑤Target lesion that is located in a native vessel distal to an anastomosis with a saphenous vein graft or a left/right internal mammary artery (LIMA/RIMA) bypass and is approached through the by-pass graft ⑥If PCI cannot be performed for other reasons☞The specific reason is recorded in the CRF
  • Unprotected left main coronary artery disease (an obstruction greater than 50% diameter stenosis in the left main coronary artery)
  • If the investigator determines that the subject is not suitable for robotic-assisted PCI due to clinical and anatomical reasons.☞The specific reason is recorded in the CRF.

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

Other trials in South Korea

About this study

Official title: Safety and Efficacy of PCI Cardiac Mapping System Workstation 'AVIAR (MX-02)' in Patients Undergoing Percutaneous Coronary Intervention (PCI): Prospective, Multi-center, Single-arm, Open, Post-approval Clinical Trial

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).

Read the detailed description

The potential subjects who meet the "Coronary Angiography Selection/Exclusion Criteria" are eligible to be enrolled in the clinical trial. These individuals 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. 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.

Keywords
Robotic PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. Technical Success Criteria

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

    Measured: 48hours

  3. 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

    Measured: 48hours

  4. 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.

    Measured: 48hours

Secondary outcomes (2)

  1. TEAE

    treatment emergent adverse event, TEAE

    Measured: 1month

  2. 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.

  1. First posted8 Aug 2023
  2. Study start16 Oct 2023
  3. Primary completion25 Mar 2024
  4. Study completion26 Apr 2024

Resources

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
21 participants (actual)
Target duration
1 Month
IDs, dates and publications
ClinicalTrials.gov ID
NCT05981859
Sponsor's protocol ID
2023-0838
Acronym
RoboticPCI
Status last verified
Jul 2024
First submitted
1 Aug 2023
Last updated
17 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39733457

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 6 inclusion and 33 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: finished, as of the sponsor's last update on 17 Jul 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

On the ClinicalTrials.gov record for NCT05981859, which also lists 1 linked publication.

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 17 Jul 2024.

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