Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04931784
• Other study ID #: INHAUH 2018-03-009
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: June 2021
• Source: Inha University Hospital
• Contact: Sang-Don Park, Ph.D
• Phone: 821033356991
• Email: denki1[@]inha.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Vasodilation

Intervention

Drug:
• Nitrate
Administration of intra-coronary nitrate before percutaneous coronary intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Inha University Hospital	Terumo Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean stent diameter		Immediately after percutaneous coronary intervention
Secondary	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