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Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention

Study acronym: OCTIVUS
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Study completion date: Jan 31, 2028 to Jan 31, 2027v16
  2. 2 versions Re-verified since Dec 18, 2023, no change to tracked fieldsv14-v15
  3. Primary endpoint revised
    • Secondary endpoints revised (14)
    v13
  4. Study sites: 6 to 9
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: 17 to 14
    v12
  5. Enrollment target: 2014 to 2008
    • Primary completion date changed from estimate of Jan 15, 2023 to Feb 17, 2023
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Trial status: Recruiting to Active, Not Recruitingv10 Show 4 more changesShow less
    • Enrollment target: estimated 2000 to confirmed 2014
    • Study sites: 7 to 6
    • Primary completion date: Dec 15, 2022 to Jan 15, 2023
    • Study completion date: Dec 31, 2027 to Jan 31, 2028
  2. Primary completion date: Jun 15, 2021 to Dec 15, 2022
    • Study sites: 3 to 7
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    v9
  3. Eligibility criteria expanded, about 30 words
    • Secondary endpoints: 15 to 17
    v8
  4. Eligibility criteria expanded, about 13 words
    • Site details revised at 1 of 3 sites
    v7
  5. Study sites: 1 to 3v6
  6. Re-verified, no change to tracked fieldsv5
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 15, 2018 to Apr 12, 2018
    • Site details revised
    v4
  8. Re-verified, no change to tracked fieldsv3
  9. Secondary endpoints: details revised at 1 of 15 entriesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Seung-Jung Park
22 trials monitored
See 1 trial at risk
The primary aim of this study is to compare the clinical efficacy and safety of OCT-guided(optical coherence tomography (OCT)-guided) and IVUS-guided(Intravascular ultrasound (IVUS)-guided) strategies in patients undergoing Percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) or drug-coated balloons (only for in-stent restenosis) for significant obstructive Coronary artery disease (CAD). 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.
Trial Details
NCT Number NCT03394079
Lead Sponsor Seung-Jung Park
Collaborators: CardioVascular Research Foundation, Korea
Conditions
(from sponsor)		 Coronary Vessels
Enrollment 2,008 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov