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NCT04931784

Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels

Status unknown NA Last updated 18 June 2021
What this trial tests

NA trial testing Nitrate in Vasodilation in 400 participants. Status unknown.

Timeline
1 August 2021
Primary endpoint
31 July 2023
31 July 2024

Quick facts

Lead sponsorInha University Hospital
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment400
Start date1 August 2021
Primary completion31 July 2023
Estimated completion31 July 2024

Drugs / interventions tested

Conditions studied

Sponsor

Inha University Hospital

Who can join

Adults 19 to 90, any sex, with Vasodilation or Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A prospective double-blinded randomized study on drug-eluting stent implantation into nitrate-induced maximally dilated vessels in patients with coronary artery disease.
    Yoon GS, Choi SH, Kwon SW, Park SD, et al · · 2023 · cited 1× · PMID 37464355 · DOI 10.1186/s13063-023-07497-5

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Other trials of Nitrate

Trials testing the same drug.

Other recruiting trials for Vasodilation

Currently open trials in the same condition.

Other Inha University Hospital trials

Trials by the same sponsor.

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Data sources for this page

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