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Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice

Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice; A MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03967158
Acronym
IRIS Sierra
Enrollment
2000
Registered
2019-05-30
Start date
2019-12-23
Completion date
2028-12-31
Last updated
2026-01-02

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

Conditions

Coronary Artery Disease, Coronary Disease

Keywords

Xience Sierra, Drug Eluting Stent, Percutaneous coronary intervention

Brief summary

The objective of this study is to evaluate effectiveness and safety of Xience Sierra stent in the real world daily practice as compared with other drug-eluting stents.

Interventions

DEVICEXience Sierra stent

Percutaneous coronary intervention with Xience Sierra stent

Sponsors

CardioVascular Research Foundation, Korea
CollaboratorOTHER
Seung-Jung Park
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 19 and more * Patient with Xience Sierra Everolimus eluting coronary stent * Written consent

Exclusion criteria

* Intervention with Xience Sierra Everolimus eluting coronary stent and other drug eluting stent at the same time * Life-expectancy less than 1 year * Cardiac shock

Design outcomes

Primary

MeasureTime frame
Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)1 year

Secondary

MeasureTime frameDescription
Cardiac death5 year
Myocardial Infarction5 year
Composite event rate of death or myocardial infarction (MI)5 year
Composite event rate of cardiac death or myocardial infarction (MI)5 year
All cause death5 year
Target- Lesion Revascularization5 year
Stent thrombosis5 year
Stroke5 year
Procedural Success rate5 yearProcedural success rate is defined as \< 30 % final stenosis and the absence of in-hospital event including death, myocardial infarction, repeat revascularization.
Target- Vessel Revascularization5 year

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026