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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04931784
Enrollment
400
Registered
2021-06-18
Start date
2021-08-01
Completion date
2024-07-31
Last updated
2021-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasodilation, Coronary Artery Disease

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.

Interventions

Administration of intra-coronary nitrate before percutaneous coronary intervention

Sponsors

Terumo Corporation
CollaboratorINDUSTRY
Inha University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mean stent diameterImmediately after percutaneous coronary intervention

Secondary

MeasureTime 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

Contacts

Primary ContactSang-Don Park, Ph.D
denki1@inha.ac.kr821033356991

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026