VasodilationNCT04931784
Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels
A study testing Nitrate in people with Vasodilation and Coronary Artery Disease, run by Inha University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Vasodilation, Coronary Artery Disease
- What is being tested?
- Nitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
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
- Being tested
- Nitrate
- Medical subject headings
- Aneurysm, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitrateDrug
Also called No intervention
Administration of intra-coronary nitrate before percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| Nitrate Group | Active comparator | with administration of intra-coronary nitrate before percutaneous coronary intervention Receives: Drug: Nitrate |
| Control Group | Placebo comparator | without administration of intra-coronary nitrate before percutaneous coronary intervention Receives: Drug: Nitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean stent diameter
Measured: 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)
Measured: 1 year after percutaneous coronary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Aug 2021 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VasodilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Terumo Corporation
- Responsible party
- Principal investigator, Sang-Don Park, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931784
- Sponsor's protocol ID
- INHAUH 2018-03-009
- Status last verified
- Jun 2021
- First submitted
- 7 Jun 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37464355
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04931784
- Acronym / sponsor ID
- INHAUH 2018-03-009
- Conditions
- Vasodilation, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Collaborators
- Terumo Corporation
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrate Group | Active comparator | Drug: Nitratewith administration of intra-coronary nitrate before percutaneous coronary intervention |
| Control Group | Placebo comparator | Drug: Nitratewithout administration of intra-coronary nitrate before percutaneous coronary intervention |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 19 years old
- evidence of coronary artery disease including asymptomatic ischemia stable angina acute coronary syndrome (unstable angina, non-ST segment elevation
- coronary artery diameter 2.25~3.5mm, stenosis 50% or more
- Those who voluntarily agreed in writing to participate in this clinical study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NitrateAlso: No interventionAdministration of intra-coronary nitrate before percutaneous coronary intervention | Drug | Control Group, Nitrate Group |
Primary outcome
Mean stent diameter
Time frame: Immediately after percutaneous coronary intervention
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Derived from this study: PubMed 37464355Yoon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrate in people with Vasodilation and Coronary Artery Disease, run by Inha University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang-Don Park, Ph.D (821033356991, denki1@inha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean stent diameter (time frame: Immediately after percutaneous coronary intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04931784, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.