Through randomization using a randomization table, patients are classified as either Treatment group in maximally dilated coronary artery administered with nitrate formulation or General treatment group without nitrate preparation (control group) to evaluate whether there is a difference in diameter of the treated Ultimaster® stent and to evaluate the stability and effectiveness after the procedure.

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

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006423

Enrollment

400

Registered

2021-08-04

Start date

2021-10-01

Completion date

Unknown

Last updated

2021-08-30

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

Conditions

None listed

Interventions

Drug : Through randomization using a randomization table, subjects are selected as the control group, which is the treatment group for the maximally dilated coronary artery administered with oral or s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Coronary Artery Disease 2. Vessle diameter 2.25~3.5mm, stenosis upper 50% 3. Those who voluntarily agreed in writing to participate in this clinical trial

Exclusion criteria

Exclusion criteria: 1. Hemodynamic instability or psychogenic shock within 24 hours before Percutaneous Coronary Intervention (PCI) 2. Life expectancy within 1 year 3. If other investigators judge that it is inappropriate to participate in this study 4. Patients who cannot use vasodilators (nitrate preparations)

Design outcomes

Primary

Measure	Time frame
Average diameter diameter of the inserted stent	—

Secondary

Measure	Time frame
thrombosis;1-year target vascular failure rate;1-year heart death rate; 1-year myocardial infarction rate	—

Countries

Korea, Republic of

Contacts

Public ContactSang-don Park

Inha University Hospital

luvorange7@naver.com+82-32-890-2555

Outcome results