Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Vasodilation
• Intervention / Treatment: Drug: Nitrate

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sang-Don Park, Ph.D; Phone Number: 821033356991; Email: denki1@inha.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Inha University Hospital
• Collaborators: Terumo Corporation

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): July 31, 2024

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 11, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: INHAUH 2018-03-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No