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Status unknownNCT04931784Updated Jun 18, 2021

Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels

An interventional study of Nitrate in Vasodilation and Coronary Artery Disease, sponsored by Inha University Hospital. Status unknown. Open to participants aged 19 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-06-18.

Sponsored by Inha University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
19 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Vasodilation
  • Coronary Artery Disease
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 400 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Inha University Hospital is the lead sponsor of 37 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 90 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
400 participants (estimated)

Study arms

  • Active comparator
    Nitrate Group

    with administration of intra-coronary nitrate before percutaneous coronary intervention

    Drug: Nitrate

  • Placebo comparator
    Control Group

    without administration of intra-coronary nitrate before percutaneous coronary intervention

    Drug: Nitrate

Interventions

  • DrugNitrate

    Administration of intra-coronary nitrate before percutaneous coronary intervention

    Also known as: No intervention

06

What researchers measure

Primary outcomes

  1. Mean stent diameter

    Time frame: 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)

    Time frame: 1 year after percutaneous coronary intervention

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04931784
Lead sponsor
Inha University Hospital
Collaborators
Terumo Corporation
Responsible party
Sang-Don Park (Associate Professor, Inha University Hospital) — Principal investigator
First posted
Jun 18, 2021
Start date
Aug 1, 2021 (estimated)
Primary completion
Jul 31, 2023 (estimated)
Completion
Jul 31, 2024 (estimated)
Last update
Jun 18, 2021

Study contacts

Sang-Don Park, Ph.D
Contact
denki1@inha.ac.kr
821033356991

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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