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| Name | Class |
|---|---|
| Terumo Corporation | INDUSTRY |
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In patients with vasospasm or with negative remodeling, various vasodilator drugs used during coronary angiography can dilate the diameter of the reference vessel to measure the exact vessel size. In particular, nitrates are well known to induce pharmacological vasodilatory effects through vascular smooth muscle relaxation In actual clinical practice, it has been reported that when oral or spray-type nitrate preparations are administered to coronary artery stenosis lesions, the diameter of the reference vessel expands by about 10% compared to the existing vessel diameter. This may enable larger stenting in coronary artery stenosis lesions. Although many patients with vascular stenosis are accompanied by vasospasm and voice remodeling, in actual clinical practice, administration of vasodilators is only used in a small number of patients at the discretion of the surgeon. Nitrate vasodilators administered during coronary angiography are low-dose and short-acting drugs, and although a small number of patients may experience side effects such as short-term lowering of blood pressure, no serious side effects are reported .
On this background, this study is to evaluate whether there is a difference in the diameter of the Ultimaster® stent treated with the conventional method compared to the maximally dilated coronary artery, and to evaluate the stability and effectiveness after the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitrate Group | Active Comparator | with administration of intra-coronary nitrate before percutaneous coronary intervention |
|
| Control Group | Placebo Comparator | without administration of intra-coronary nitrate before percutaneous coronary intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitrate | Drug | Administration of intra-coronary nitrate before percutaneous coronary intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean stent diameter | Immediately after percutaneous coronary intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Failure rate of target lesion for 1-year (combination of cardiac death, target vascular myocardial infarction, target vascular revascularization) | 1 year after percutaneous coronary intervention |
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Inclusion Criteria:
Over 19 years old
evidence of coronary artery disease including asymptomatic ischemia stable angina acute coronary syndrome (unstable angina, non-ST segment elevation
coronary artery diameter 2.25~3.5mm, stenosis 50% or more
Those who voluntarily agreed in writing to participate in this clinical study
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sang-Don Park, Ph.D | Contact | 821033356991 | denki1@inha.ac.kr |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37464355 | Derived | Yoon GS, Choi SH, Kwon SW, Park SD, Woo SI. A prospective double-blinded randomized study on drug-eluting stent implantation into nitrate-induced maximally dilated vessels in patients with coronary artery disease. Trials. 2023 Jul 18;24(1):460. doi: 10.1186/s13063-023-07497-5. |
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| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
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| ID | Term |
|---|---|
| D009566 | Nitrates |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D017942 |
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| D006331 |
| Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| Nitric Acid |
| D017672 | Nitrogen Compounds |
| D009930 | Organic Chemicals |