Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels

NCT04931784 | Unknown

• 1 other identifier: INHAUH 2018-03-009
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vasodilation; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Mean stent diameter

  Immediately after percutaneous coronary intervention

Secondary Outcomes (1)

• 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

Study Arms (2)

Nitrate Group

ACTIVE COMPARATOR

with administration of intra-coronary nitrate before percutaneous coronary intervention

Drug: Nitrate

Control Group

PLACEBO COMPARATOR

without administration of intra-coronary nitrate before percutaneous coronary intervention

Drug: Nitrate

Interventions

Nitrate DRUG

Administration of intra-coronary nitrate before percutaneous coronary intervention

Also known as: No intervention

Control Group; Nitrate Group

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inha University Hospital: lead
• Terumo Corporation: collaborator

Related Publications (1)

• Yoon GS, Choi SH, Kwon SW, Park SD, Woo SI. A prospective double-blinded randomized study on drug-eluting stent implantation into nitrate-induced maximally dilated vessels in patients with coronary artery disease. Trials. 2023 Jul 18;24(1):460. doi: 10.1186/s13063-023-07497-5.

  PMID: 37464355 DERIVED

MeSH Terms

Conditions

Aneurysm; Coronary Artery Disease

Interventions

Nitrates

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Nitric Acid; Nitrogen Compounds; Organic Chemicals

Central Study Contacts

Sang-Don Park, Ph.D

CONTACT

821033356991; denki1@inha.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 18, 2021
• Study Start: August 1, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2024
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share