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

Recruiting

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

• Registration Number: NCT03866486
• Lead Sponsor: Yonsei University

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).

Study Timeline

• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-07
• Study Start: 2019-03-15
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-12
• Last Update Posted: 2020-10-14
• Primary Completion: 2024-07-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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.

Secondary Outcome Measures

Name	Time	Method
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 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 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.
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.
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.
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.
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 10 years	At 10 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.
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.
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.
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.
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 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.

Trial Locations

Locations (1)

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of