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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03866486

Enrollment

1400

Registered

2019-03-07

Start date

2019-03-15

Completion date

2025-01-31

Last updated

2020-10-14

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

Conditions

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

Keywords

Clinical outcome; IVUS; Stent

Brief summary

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.

Detailed description

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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	At 5 years	Major adverse cardiac events will be included the composite of cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization.

Secondary

Measure	Time frame	Description
Target-lesion related stent thrombosis at 5 years	At 5 years	Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
Cardiac death at 5 years	At 5 years	Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
Cardiac death at 10 years	At 10 years	Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
All-cause of death at 5 years	At 5 years	Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
All-cause of death at 10 years	At 10 years	Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
Target-lesion related myocardial infarction at 5 years	At 5 years	Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
Target-lesion related myocardial infarction at 10 years	At 10 years	Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
Any revascularization at 10 years	At 10 years	Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
Any myocardial infarction at 10 years	At 10 years	Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
Target-lesion revascularization at 5 years	At 5 years	Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
Target-lesion revascularization at 10 years	At 10 years	Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
Any revascularization at 5 years	At 5 years	Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
Target-lesion related stent thrombosis at 10 years	At 10 years	Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
Any stent thrombosis at 5 years	At 5 years	Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
Any stent thrombosis at 10 years	At 10 years	Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
Any myocardial infarction at 5 years	At 5 years	Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

Countries

South Korea

Contacts

Primary ContactMyeong-Ki Hong, PhD

mkhong61@yuhs.ac82-2-2228-8460

Outcome results