Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2024-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Different Vasodilators on Coronary No-reflow During primAry percuTaneous Coronary intErvention in Patients With Acute Myocardial Infarction

NCT00712894

Acute Myocardial Infarction Percutaneous Coronary Intervention

COMPLETED PHASE4

Nitrites in Acute Myocardial Infarction

NCT01388504

Acute ST Elevation Myocardial Infarction

COMPLETED PHASE2/PHASE3

Coronary Artery Endothelial Dysfunction With Drug Coated Balloons

NCT04901767

Coronary Artery Disease Ischaemic Heart Disease Endothelial Dysfunction

COMPLETED

The Effect of Sublingual Nitroglycerin on Absolute Coronary Blood Flow

NCT06823843

Coronary Arterial Disease (CAD) Angina (Stable)

COMPLETED PHASE4

Transradial Evaluation Study of Diameter Increase After Vasodilatory Drugs Administration.

NCT04317846

Arterial Spasm Coronary Artery Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vasodilation Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nitrate Group

with administration of intra-coronary nitrate before percutaneous coronary intervention

Group Type ACTIVE_COMPARATOR

Nitrate

Intervention Type DRUG

Administration of intra-coronary nitrate before percutaneous coronary intervention

Control Group

without administration of intra-coronary nitrate before percutaneous coronary intervention

Group Type PLACEBO_COMPARATOR

Nitrate

Intervention Type DRUG

Administration of intra-coronary nitrate before percutaneous coronary intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nitrate

Administration of intra-coronary nitrate before percutaneous coronary intervention

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

No intervention

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No