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

An observational study of Myocardial Ischemia(Implanted Drug-eluting Stents Because of Ischemic Heart Disease(Stable Angina, Acute Coronary Syndrome)), run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 85 years
How many people
1,400 participants
Where
1 siteSouth Korea
Study dates
15 Mar 2019to 31 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 1. The patients who enrolled in the XPL-IVUS study.
  • 2. Provision of informed consent

Who cannot join

  • 1. This observational study does not have any specific exclusion criteria.

Trial locations and contacts

1 site in 1 country.

Myeong-Ki Hong, PhD contact

82-2-2228-8460

mkhong61@yuhs.ac

South Korea1 site, 1 recruiting

  • Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine

    Seoul, 120-752

    MYEONG-KI HONG, MD, Ph.D, 82-2-2228-8460, MKHONG61@yuhs.ac

    Recruiting

Other trials in South Korea

About this 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.

Read the 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).

Keywords
Clinical outcome; IVUS; Stent
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03866486
Study groupRoleWhat they receive
IVUS-guidance groupThe patients who underwent drug-eluting stents implantation with IVUS guidance.
Angiography-guidance groupThe patients who underwent drug-eluting stents implantation with angiography guidance without IVUS.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At 5 years

  2. 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.

    Measured: At 10 years

Secondary outcomes (16)

  1. Cardiac death at 5 years

    Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

    Measured: At 5 years

  2. Cardiac death at 10 years

    Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

    Measured: At 10 years

  3. 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.

    Measured: At 5 years

  4. 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.

    Measured: At 10 years

  5. 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.

    Measured: At 5 years

  6. 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.

    Measured: At 10 years

  7. Any myocardial infarction at 5 years

    Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

    Measured: At 5 years

  8. Any myocardial infarction at 10 years

    Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

    Measured: At 10 years

  9. Target-lesion revascularization at 5 years

    Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

    Measured: At 5 years

  10. Target-lesion revascularization at 10 years

    Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

    Measured: At 10 years

  11. Any revascularization at 5 years

    Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

    Measured: At 5 years

  12. Any revascularization at 10 years

    Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

    Measured: At 10 years

  13. 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.

    Measured: At 5 years

  14. 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.

    Measured: At 10 years

  15. Any stent thrombosis at 5 years

    Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

    Measured: At 5 years

  16. Any stent thrombosis at 10 years

    Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.

    Measured: At 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2019
  2. Study start15 Mar 2019
  3. Primary completion31 Jul 2024 (estimated)
  4. Study completion31 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
1,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03866486
Sponsor's protocol ID
4-2018-1153
Status last verified
Oct 2020
First submitted
4 Mar 2019
Last updated
14 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 31918944

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Ischemia(Implanted Drug-eluting Stents Because of Ischemic Heart Disease(Stable Angina, Acute Coronary Syndrome)), run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Myeong-Ki Hong, PhD (82-2-2228-8460, mkhong61@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: At 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03866486, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.

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