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Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention (OCTIVUS)

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ClinicalTrials.gov Identifier: NCT03394079
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

Brief Summary:
This study is to establish the primary hypothesis that Optical coherence tomography-guided Percutaneous coronary intervention(OCT-guided PCI) is non-inferior to Intravascular ultrasound-guided Percutaneous coronary intervention(IVUS-guided PCI) regarding the target vessel failure at 1 year.

Condition or disease Intervention/treatment Phase
Coronary Vessels Procedure: PCI Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open Label, Multi-center, Dual Arm, Randomized, Pragmatic Trial : Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention
Actual Study Start Date : April 12, 2018
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : December 31, 2026

Arm Intervention/treatment
Experimental: OCT-guided Procedure: PCI
Percutaneous Coronary Intervention

Active Comparator: IVUS-guided Procedure: PCI
Percutaneous Coronary Intervention




Primary Outcome Measures :
  1. Target vessel failure [ Time Frame: 1 year ]
    the cumulative incidence of cardiac death, target vessel myocardial infarction or ischemia-driven target vessel revascularization at 1 year after the index procedure


Secondary Outcome Measures :
  1. Device success [ Time Frame: 1 hour ]
    Lesion level analysis : Successful PCI at the intended target lesion with final instant residual stenosis of less than 30% by quantitative coronary angiography (QCA)

  2. Death [ Time Frame: 1, and 5 years ]
    cardiac, vascular, non-cardiovascular death

  3. Myocardial infarction [ Time Frame: 1, and 5 years ]
    periprocedural/spontaneous MI

  4. Stent thrombosis [ Time Frame: 1, and 5 years ]
    definite/probable

  5. Stroke [ Time Frame: 1, and 5 years ]
    Stroke is defined as focal loss of neurologic function caused by an ischemic or hemorrhagic event, with residual symptoms lasting at least 24 hours or leading to death.

  6. Any revascularization [ Time Frame: 1, and 5 years ]
  7. Target lesion revascularization [ Time Frame: 1, and 5 years ]
  8. Target vessel revascularization [ Time Frame: 1, and 5 years ]
  9. Repeat hospitalization [ Time Frame: 1, and 5 years ]
  10. Acute kidney injury [ Time Frame: 7 days ]
    after index procedure before discharge

  11. Target lesion failure [ Time Frame: 1, and 5 years ]
    cardiac death, target vessel MI or ischemia-driven TLR

  12. A composite event of all-cause death and spontaneous MI [ Time Frame: 1, and 5 years ]
    A composite event of all-cause death and spontaneous MI is defined as the occurrence of either all-cause death, spontaneous MI, or both and denoted that event as the union of endpoint all-cause death and endpoint spontaneous MI.

  13. A composite of cardiac death and spontaneous MI [ Time Frame: 1, and 5 years ]
    A composite event of cardiac death and spontaneous MI is defined as the occurrence of either cardiac death, spontaneous MI, or both and denoted that event as the union of endpoint cardiac death and endpoint spontaneous MI.

  14. A composite of all-cause death, any MI, any repeat revascularization [ Time Frame: 1, and 5 years ]
    A composite event of all-cause death, any MI, any repeat revascularization is defined as the occurrence of any event from all-cause death, any MI, any repeat revascularization and denoted that event as the union of endpoint all-cause death, endpoint any MI, and endpoint any repeat revascularization.

  15. A composite of cardiac death, target vessel MI, stroke, or clinically significant bleeding [ Time Frame: 1, and 5 years ]

    A composite event of cardiac death, target vessel MI, stroke, or clinically significant bleeding is defined as the occurrence of any event from cardiac death, target vessel MI, stroke, clinically significant bleeding and denoted that event as the union of endpoint cardiac death, endpoint target vessel MI, endpoint stroke, and endpoint clinically significant bleeding.

    clinically significant bleeding : Bleeding Academic Research Consortium (BARC) type 2,3,4,5




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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women at least 19 years of age
  • Subjects with coronary artery disease undergoing PCI
  • The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

  • ST-elevation myocardial infarction
  • Cardiogenic shock or decompensated heart failure with severe LV dysfunction (LVEF) < 30%
  • Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
  • Life expectancy < 1 years for any non-cardiac or cardiac causes
  • Unwillingness or inability to comply with the procedures described in this protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394079


Contacts
Contact: Seung-jung Park, MD 82230104812 sjpark@amc.seoul.kr
Contact: Jung-hee Ham, RN 82230104728 cvcrc5@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Hospital Recruiting
Seoul, Korea, Republic of
Contact: Seung-jung Park, MD       sjpark@amc.seoul.kr   
Principal Investigator: Seung-jung Park, MD         
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea

Responsible Party: Seung-Jung Park, Professor, Division of Cardiology, Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, South Korea, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03394079     History of Changes
Other Study ID Numbers: AMCCV2017-10
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Seung-Jung Park, Asan Medical Center:
OCT
IVUS
PCI