Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels

Inha University Hospital

Status: Not yet enrolling

Conditions: Coronary Artery Disease; Vasodilation

Treatments: Drug: Nitrate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04931784

INHAUH 2018-03-009

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 19 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups, including a placebo group

Nitrate Group

Active Comparator group

Description:

with administration of intra-coronary nitrate before percutaneous coronary intervention

Treatment:

Drug: Nitrate

Control Group

Placebo Comparator group

Description:

without administration of intra-coronary nitrate before percutaneous coronary intervention

Treatment:

Drug: Nitrate