Myocardial Ischemia(Implanted Drug-eluting Stents Because of Ischemic Heart Disease(Stable Angina, Acute Coronary Syndrome)) Clinical Trial
Official title:
Impact of IntraVascular UltraSound Guidance on the Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL Study): Retrospective and Prospective Follow-up Study
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.
| Status | Recruiting |
| Enrollment | 1400 |
| Est. completion date | January 31, 2025 |
| Est. primary completion date | July 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 85 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | At 5 years | |
| Primary | 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. | At 10 years | |
| Secondary | Cardiac death at 5 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 5 years | |
| Secondary | Cardiac death at 10 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 10 years | |
| Secondary | 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. | At 5 years | |
| Secondary | 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. | At 10 years | |
| Secondary | 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. | At 5 years | |
| Secondary | 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. | At 10 years | |
| Secondary | Any myocardial infarction at 5 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 5 years | |
| Secondary | Any myocardial infarction at 10 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 10 years | |
| Secondary | Target-lesion revascularization at 5 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 5 years | |
| Secondary | Target-lesion revascularization at 10 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 10 years | |
| Secondary | Any revascularization at 5 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 5 years | |
| Secondary | Any revascularization at 10 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 10 years | |
| Secondary | 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. | At 5 years | |
| Secondary | 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. | At 10 years | |
| Secondary | Any stent thrombosis at 5 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 5 years | |
| Secondary | Any stent thrombosis at 10 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 10 years |