Safety and efficacy of AVIAR in patients undergoing percutaneous coronary intervention (PCI)
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0008679
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 21
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:
1.If the lesion to be treated by coronary angiography (target lesion) is a native coronary artery lesion that has not been previously treated
2.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).
3.If diameter stenosis of the target vessel =50% (by visual estimate)
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 a medically acceptable method of contraception** during the clinical trial
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety is assessed through the occurrence of treatment-emergent adverse events (TEAEs) and major adverse cardiovascular events (MACE) that occur in the study subjects during the clinical trial period.;The evaluation variables for demonstrating efficacy are clinical success rate (N%), technical success rate (N%), effective dose (mSv), and procedure duration (min).
- Secondary Outcome Measures
Name Time Method If necessary, subgroup analysis based on the approach route for percutaneous coronary intervention (PCI) (femoral artery, radial artery) may be conducted.