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An observational study to evaluate the effectiveness and safety of sirolimus-eluting stents in patients at high risk of cardiovascular disease

Clinical outcomes of Ultimaster Tansei sirolimus-eluting coronary stent in Complex High-risk Indicated Patients Percutaneous Coronary Intervention

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0005639
Enrollment
1500
Registered
2020-11-27
Start date
2020-11-25
Completion date
Unknown
Last updated
2020-12-02

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

Keimyung University Dongsan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: * Patients with one of the following conditions among coronary artery disease requiring sirolimus-eluting coronary stent (UltimasterTM TanseiTM) treatment ? Complex coronary artery disease -multi-vessel disease-left main disease-severe calcified lesion -chronic total occlusion lesion-bifurcation lesion -diffuse long lesion-small vessel lesion-ostial lesion -thrombus containing lesion-in-stent restenosis lesion -vein graft lesion ? Patient comorbidities -advanced age (=80 years old)-acute coronary syndrome -diabetes-chronic kidney disease (creatinine >1.5 mg/dL) -heart failure (NYHA GIII-IV) -depressed left ventricular function (ejection fraction <50%) -prior cardiac surgery-cardiogenic shock * Patients who have agreed on the study plan and clinical follow-up schedule, and have previously agreed in writing as approved by the research review committee/ethics committee of each clinical research institution

Exclusion criteria

Exclusion criteria: * When administration of the following drugs is prohibited: aspirin, heparin, clopidogrel, control substance or sirolimus * During the first 6 months post-registration period, pending surgery that requires intervention with antiplatelet drugs is planned. * Women who are lactating, pregnant or wishing to become pregnant * Terminal disease with a lifespan of less than 1 year

Design outcomes

Primary

MeasureTime frame
Target lesion treatment failure—

Secondary

MeasureTime frame
Target lesion treatment failure;Target vessel treatment failure;All Death;Cardiac death;All Death and Myocardial infarction;Cardiac Death and Myocardial infarction;Ischemia-driven Target lesion retreatment;Ischemia-driven Target vessel retreatment;Stent Thrombosis;Bleeding—

Countries

Korea, Republic of

Contacts

Public ContactSeung-Ho Hur

Keimyung University Dongsan Medical Center

Outcome results

None listed

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