Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Prospective, Open, Randomized Study Comparing the Effects of Ultimaster® Stents Treated With Conventional Methods on Coronary Artery Lesions Compared to the Most Dilated Coronary Vessels

Conditions
-----------------
Vasodilation, Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Nitrate


Participation Criteria
=================
Eligibility Criteria
-----------------
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 myocardial infarction, ST segment elevation myocardial infarction). 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: instability or psychogenic shock within 24 hours before percutaneous coronary intervention life expectancy no longer than 1 year hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel patients whom researchers think unsuitable for participation in this study

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nitrate Group<br>with administration of intra-coronary nitrate before percutaneous coronary intervention | Drug: Nitrate<br>* Administration of intra-coronary nitrate before percutaneous coronary intervention<br>* Other names: No intervention;|
| Placebo Comparator: Control Group<br>without administration of intra-coronary nitrate before percutaneous coronary intervention | Drug: Nitrate<br>* Administration of intra-coronary nitrate before percutaneous coronary intervention<br>* Other names: No intervention;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean stent diameter |  | Immediately after percutaneous coronary intervention | 

Secondary Outcome Measures

| Outcome Measure | 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 |