Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention
NCT ID: NCT03394079
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
2008 participants
INTERVENTIONAL
2018-04-12
2028-01-31
Brief Summary
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The investigators hypothesize that OCT-guided PCI is non-inferior to IVUS-guided PCI with respect to primary end point of target-vessel failure (cardiac death, target-vessel myocardial infarction \[MI\], or ischemia-driven target-vessel revascularization \[TVR\]) at 1 year after randomization.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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OCT-guided
PCI
Percutaneous Coronary Intervention
IVUS-guided
PCI
Percutaneous Coronary Intervention
Interventions
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PCI
Percutaneous Coronary Intervention
Eligibility Criteria
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Inclusion Criteria
* Subjects with obstructive CAD undergoing PCI with contemporary DES or drug-coated balloons (only for in-stent restenosis) under intracoronary imaging guidance.
* 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
* Severe renal dysfunction (eGFR \<30 ml/min/1.73 m2 or serum creatinine level \>1.5 mg/dl), unless patient is on renal replacement therapy.
* Cardiogenic shock or decompensated heart failure with severe LV dysfunction (LVEF) \< 30%
* Life expectancy \< 1 year for any non-cardiac or cardiac causes
* Any lesion characteristics resulting in the expected inability to deliver the IVUS or OCT catheter to the lesion pre- and post-PCI (eg, moderate or severe vessel calcification or tortuosity)
* 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
* Unwillingness or inability to comply with the procedures described in this protocol
19 Years
ALL
No
Sponsors
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CardioVascular Research Foundation, Korea
OTHER
Seung-Jung Park
OTHER
Responsible Party
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Seung-Jung Park
Professor, Division of Cardiology, Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, South Korea
Principal Investigators
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Duk-woo Park, MD
Role: PRINCIPAL_INVESTIGATOR
Professor, Division of Cardiology, Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, South Korea
Locations
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Keimyung University Dongsan Medical Center
Daegu, , South Korea
Konyang University Hospital
Daejeon, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Pusan National University Hospital
Pusan, , South Korea
Asan Medical Hospital
Seoul, , South Korea
Chung-Ang university hospital
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Kyung hee university hospital
Seoul, , South Korea
Countries
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References
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Kim H, Kang DY, Ahn JM, Kim HJ, Hur SH, Cho YK, Lee CH, Hong SJ, Kim SW, Won H, Oh JH, Hong YJ, Yoon YH, Park SJ, Park DW; OCTIVUS Investigators. Proportion and Clinical Impact of Stent Optimization During Imaging-Guided Percutaneous Coronary Intervention: The OCTIVUS Trial. JACC Cardiovasc Interv. 2025 May 12;18(9):1089-1099. doi: 10.1016/j.jcin.2025.01.436. Epub 2025 Apr 23.
Kang DY, Ahn JM, Yun SC, Hur SH, Cho YK, Lee CH, Hong SJ, Lim S, Kim SW, Won H, Oh JH, Choe JC, Hong YJ, Yoon YH, Kim H, Choi Y, Lee J, Yoon YW, Kim SJ, Bae JH, Park SJ, Park DW; OCTIVUS Investigators. Guiding Intervention for Complex Coronary Lesions by Optical Coherence Tomography or Intravascular Ultrasound. J Am Coll Cardiol. 2024 Jan 23;83(3):401-413. doi: 10.1016/j.jacc.2023.10.017. Epub 2023 Oct 23.
Kang DY, Ahn JM, Yun SC, Hur SH, Cho YK, Lee CH, Hong SJ, Lim S, Kim SW, Won H, Oh JH, Choe JC, Hong YJ, Yoon YH, Kim H, Choi Y, Lee J, Yoon YW, Kim SJ, Bae JH, Park DW, Park SJ; OCTIVUS Investigators. Optical Coherence Tomography-Guided or Intravascular Ultrasound-Guided Percutaneous Coronary Intervention: The OCTIVUS Randomized Clinical Trial. Circulation. 2023 Oct 17;148(16):1195-1206. doi: 10.1161/CIRCULATIONAHA.123.066429. Epub 2023 Aug 27.
Kang DY, Ahn JM, Park H, Lee PH, Kang SJ, Lee SW, Kim YH, Park SW, Kim SW, Hur SH, Cho YK, Lee CH, Hong SJ, Hong YJ, Yoon YW, Kim SJ, Bae JH, Oh JH, Park DW, Park SJ. Comparison of optical coherence tomography-guided versus intravascular ultrasound-guided percutaneous coronary intervention: Rationale and design of a randomized, controlled OCTIVUS trial. Am Heart J. 2020 Oct;228:72-80. doi: 10.1016/j.ahj.2020.08.003. Epub 2020 Aug 8.
Other Identifiers
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AMCCV2017-10
Identifier Type: -
Identifier Source: org_study_id