Clinical trial NCT04931784: Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vasodilation
Coronary Artery Disease
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
Collaborators: name: Terumo Corporation
First posted: 2021-06-18
Enrollment: 400
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mean stent diameter
timeFrame: Immediately after percutaneous coronary intervention
Secondary outcomes:
measure: Failure rate of target lesion for 1-year (combination of cardiac death, target vascular myocardial infarction, target vascular revascularization)
timeFrame: 1 year after percutaneous coronary intervention
Other outcomes:
Locations:
Study officials:
References: