Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels
Primary Purpose
Vasodilation, Coronary Artery Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nitrate
Sponsored by
About this trial
This is an interventional treatment trial for Vasodilation
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Nitrate Group
Control Group
Arm Description
with administration of intra-coronary nitrate before percutaneous coronary intervention
without administration of intra-coronary nitrate before percutaneous coronary intervention
Outcomes
Primary Outcome Measures
Mean stent diameter
Secondary Outcome Measures
Failure rate of target lesion for 1-year (combination of cardiac death, target vascular myocardial infarction, target vascular revascularization)
Full Information
NCT ID
NCT04931784
First Posted
June 7, 2021
Last Updated
June 11, 2021
Sponsor
Inha University Hospital
Collaborators
Terumo Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04931784
Brief Title
Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inha University Hospital
Collaborators
Terumo Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasodilation, Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nitrate Group
Arm Type
Active Comparator
Arm Description
with administration of intra-coronary nitrate before percutaneous coronary intervention
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
without administration of intra-coronary nitrate before percutaneous coronary intervention
Intervention Type
Drug
Intervention Name(s)
Nitrate
Other Intervention Name(s)
No intervention
Intervention Description
Administration of intra-coronary nitrate before percutaneous coronary intervention
Primary Outcome Measure Information:
Title
Mean stent diameter
Time Frame
Immediately after percutaneous coronary intervention
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang-Don Park, Ph.D
Phone
821033356991
Email
denki1@inha.ac.kr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels
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