Impact of IntraVascular UltraSound Guidance on the Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL Study): Retrospective and Prospective Follow-up Study

Yonsei University1,400 enrolled

Overview

The investigator aimed to evaluate the long-term (up to 10 years) follow-up of the patients who enrolled the IVUS-XPL study (Impact of IntraVascular UltraSound Guidance on the Outcomes of Xience Prime Stents in Long Lesions), which was shown the superiority of IVUS-guided stent implantation at 1 year in terms of major adverse cardiac events.

The investigator will follow-up (up to 10 years) the patients who enrolled the IVUS-XPL study (Impact of IntraVascular UltraSound Guidance on the Outcomes of Xience Prime Stents in Long Lesions).

Study Type

OBSERVATIONAL

Enrollment

1,400

Conditions

Myocardial Ischemia(Implanted Drug-eluting Stents Because of Ischemic Heart Disease(Stable Angina, Acute Coronary Syndrome))

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1\. The patients who enrolled in the XPL-IVUS study. * 2\. Provision of informed consent Exclusion Criteria: * 1\. This observational study does not have any specific exclusion criteria.

Locations (1)

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

The composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at 5 years and at 10 years

Major adverse cardiac events will be included the composite of cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization.

Time frame: At 5 years

The composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at 5 years and at 10 years

Major adverse cardiac events will be included the composite of cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization.

Time frame: At 10 years

Secondary Outcomes

Cardiac death at 5 years

Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

Time frame: At 5 years

Cardiac death at 10 years

Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

Time frame: At 10 years

All-cause of death at 5 years

Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

Time frame: At 5 years

All-cause of death at 10 years

Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

Time frame: At 10 years

Central Contacts

Myeong-Ki Hong, PhD

CONTACT

82-2-2228-8460 mkhong61@yuhs.ac

Data from ClinicalTrials.gov

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Target-lesion related myocardial infarction at 5 years

Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

Time frame: At 5 years

Target-lesion related myocardial infarction at 10 years

Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

Time frame: At 10 years

Any myocardial infarction at 5 years

Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

Time frame: At 5 years

Any myocardial infarction at 10 years

Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

Time frame: At 10 years

Target-lesion revascularization at 5 years

Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

Time frame: At 5 years

Target-lesion revascularization at 10 years

Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

Time frame: At 10 years

Any revascularization at 5 years

Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

Time frame: At 5 years

Any revascularization at 10 years

Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

Time frame: At 10 years

Target-lesion related stent thrombosis at 5 years

Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

Time frame: At 5 years

Target-lesion related stent thrombosis at 10 years

Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

Time frame: At 10 years

Any stent thrombosis at 5 years

Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

Time frame: At 5 years

Any stent thrombosis at 10 years

Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

Time frame: At 10 years