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A Prospective Registry to Evaluate Renal Insufficiency of the Sirolimus-Eluting Coronary Stent (UltimasterTM tansei) in Patients with Coronary Artery Disease; A Multicenter, Prospective Observational Study

A Prospective Registry to Evaluate Renal Insufficiency of the Sirolimus-Eluting Coronary Stent (UltimasterTM tansei) in Patients with Coronary Artery Disease; A Multicenter, Prospective Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0005337
Enrollment
1472
Registered
2020-08-24
Start date
2020-11-18
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

None listed

Interventions

None listed

Sponsors

The Catholic University of Korea, St. Vincent's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) All patients over the age of 19 with coronary artery disease who receive the UltimasterTM tansei stent 2) patients or legal guardians voluntarily signing the consent form and agreeing with the study protocol and the schedule for clinical follow-up.

Exclusion criteria

Exclusion criteria: 1) Patients treated with different drug stents at the time of research registration 2) Patients whose life expectancy are less than 1 year 3) Patients with cardiogenic shock or severe pulmonary edema

Design outcomes

Primary

MeasureTime frame
Combined clinical events which involve death, myocardial infarction(non-fatal) or target vessel revascularization (TVR) at 12 months after coronary intervention

Secondary

MeasureTime frame
Each of the following events which involve the followings at 12 months after coronary intervention (1) All deaths (2) Cardiac death (3) Myocardial infarction (MI) (4) Composite of death and myocardial infarction (5) Composite of cardiac death and myocardial infarction (6) Composite of death, myocardial infarction, and target vessel revascularization (7) Composite of cardiac death, myocardial infarction, and target vessel revascularization (8) Composite of death, myocardial infarction, and target lesion revascularization (9) Composite of cardiac death, myocardial infarction, target lesion revascularization (10) Target vessel revascularization (TVR) (11) Target lesion revascularization (TLR) (12) Stent thrombosis (ARC standard) (13) Procedure success(Case where there was no death nor Q-wave myocardial infarction or urgent revascularization during hospitalization as less 30% of final residual stenosis in evaluation by angiography naked eye after procedure)

Countries

Korea, Republic of

Contacts

Public ContactGyung-Min Park

Ulsan Univeristy Hospital

min8684@hanmail.net+82-52-250-8993

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026