Comparison of Safety and Efficacy Between the Robot-assisted System AVIAR (MX-02) Procedure and Conventional Manual Procedure in Patients Requiring Percutaneous Coronary Intervention
NCT ID: NCT06735716
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
80 participants
OBSERVATIONAL
2025-01-15
2026-03-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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.
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
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.
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.
19 Years
ALL
No
Sponsors
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LN Robotics inc.
UNKNOWN
Asan Medical Center
OTHER
Responsible Party
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Tae Oh Kim
Principal Investigator
Principal Investigators
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Tae-Oh kim
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, , South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Tae-Oh Kim
Role: primary
Role: backup
Other Identifiers
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2024-1271
Identifier Type: -
Identifier Source: org_study_id