Clinical trial NCT03866486: Impact of IntraVascular UltraSound Guidance on the Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL Study): Retrospective and Prospective Follow-up Study
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Ischemia(Implanted Drug-eluting Stents Because of Ischemic Heart Disease(Stable Angina, Acute Coronary Syndrome))
Keywords: Clinical outcome; IVUS; Stent
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 1400
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who enrolled in the previous IVUS-XPL study. In the IVUS-XPL trial, the patients who implatned drug-eluting stents because of ischemic heart disease (stable angina, acute coronay syndrome) were enrolled.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: At 5 years
measure: 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
timeFrame: At 10 years
Secondary outcomes:
measure: Cardiac death at 5 years
timeFrame: At 5 years
measure: Cardiac death at 10 years
timeFrame: At 10 years
measure: All-cause of death at 5 years
timeFrame: At 5 years
measure: All-cause of death at 10 years
timeFrame: At 10 years
measure: Target-lesion related myocardial infarction at 5 years
timeFrame: At 5 years
measure: Target-lesion related myocardial infarction at 10 years
timeFrame: At 10 years
measure: Any myocardial infarction at 5 years
timeFrame: At 5 years
measure: Any myocardial infarction at 10 years
timeFrame: At 10 years
measure: Target-lesion revascularization at 5 years
timeFrame: At 5 years
measure: Target-lesion revascularization at 10 years
timeFrame: At 10 years
measure: Any revascularization at 5 years
timeFrame: At 5 years
measure: Any revascularization at 10 years
timeFrame: At 10 years
measure: Target-lesion related stent thrombosis at 5 years
timeFrame: At 5 years
measure: Target-lesion related stent thrombosis at 10 years
timeFrame: At 10 years
measure: Any stent thrombosis at 5 years
timeFrame: At 5 years
measure: Any stent thrombosis at 10 years
timeFrame: At 10 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
Study officials:
affiliation: Severance Hospital
name: Myeong-Ki Hong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hong SJ, Mintz GS, Ahn CM, Kim JS, Kim BK, Ko YG, Kang TS, Kang WC, Kim YH, Hur SH, Hong BK, Choi D, Kwon H, Jang Y, Hong MK; IVUS-XPL Investigators. Effect of Intravascular Ultrasound-Guided Drug-Eluting Stent Implantation: 5-Year Follow-Up of the IVUS-XPL Randomized Trial. JACC Cardiovasc Interv. 2020 Jan 13;13(1):62-71. doi: 10.1016/j.jcin.2019.09.033.