KCT0009601Not yet recruitingUnknown
Evaluation of safety and efficacy of Cardiac mapping system workstation ‘AVIAR (MX-02)’ in percutaneous coronary intervention (PCI) requiring multiple guide wires: A prospective, single-center, single-arm, open-label investigator-initiated clinical trial
The Catholic University of Korea, Eunpyeong St. Mary's Hospital0 sites10 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 19(Year) to o Limit (—)
- Sex
- All
Inclusion Criteria
- •1. Adult women and men who are aged =19
- •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:
- •5. If the lesion to be treated by coronary angiography (target lesion) is a native coronary artery lesion that has not been previously treated
- •6. If the lesion is a bifurcation lesion and the operator determines that additional guide wire usage is necessary to protect the side branch vessel.
- •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
- •General Exclusion Criteria:
- •1. Those with a left ventricular ejection fraction (LVEF) = 30%
- •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.
- •Angiographic Exclusion Criteria:
- •20. Those who require manual or mechanical thrombectomy, rotational atherectomy, directional coronary atherectomy (DCA), etc. in addition to stent placement and balloon dilatation
- •21. When the two-stent technique is required for the side branch of the target bifurcation lesion.
- •22. 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
- •?The target vessel has evidence of intraluminal thrombus or severe tortuosity (> 90°) proximal to the target lesion
- •?Moderate or severe calcification at the target lesion or near the target lesion
- •?Target lesion that is located in a native v
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