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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 1400

Contacts and Locations

• Study Contact: Name: Myeong-Ki Hong, PhD; Phone Number: 82-2-2228-8460; Email: mkhong61@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Recruiting
    • Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
    • Contact: MYEONG-KI HONG, MD, Ph.D; Phone Number: 82-2-2228-8460; Email: MKHONG61@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
IVUS-guidance group; The patients who underwent drug-eluting stents implantation with IVUS guidance.
Angiography-guidance group; The patients who underwent drug-eluting stents implantation with angiography guidance without IVUS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Myeong-Ki Hong, PhD, Severance Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2019
• Primary Completion (Anticipated): July 31, 2024
• Study Completion (Anticipated): January 31, 2025

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 5, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Clinical outcome; IVUS; Stent
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Chest Pain; Angina Pectoris; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Ischemia; Acute Coronary Syndrome; Angina, Stable
• Other Study ID Numbers: 4-2018-1153

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No