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Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Intermediate Left Main Coronary Artery Lesions

Study acronym: EMPERATRIZ
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Mar 20, 2026 → Mar 20, 2027
See other at-risk trials from Fundación EPIC

Record History

  1. Primary completion pushed from Mar 20, 2026 to Mar 20, 2027 Completion pushed from Apr 20, 2026 to Mar 20, 2027 · Eligibility criteria expanded, about 9 words · Secondary endpoints: details revised at 4 of 9 entries · 3 more Show 6 more changesShow less
    • Completion pushed from Apr 20, 2026 to Mar 20, 2027
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 4 of 9 entries
    • Study description revised
    • Site details revised at 1 of 18 sites
    • Publications: details revised at 5 of 5 entries
  2. Primary completion date: Jan 20, 2026 to Mar 20, 2026 Completion date: Jan 20, 2026 to Apr 20, 2026v16 Show 1 more changeShow less
    • Completion date: Jan 20, 2026 to Apr 20, 2026
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 129 to confirmed 153 · Site details revised at 18 of 18 sitesv15 Show 2 more changesShow less
    • Enrollment target: estimated 129 to confirmed 153
    • Site details revised at 18 of 18 sites
  4. Study sites: 17 to 18v14
  5. Primary completion date: Jan 20, 2025 to Jan 20, 2026v13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 16 to 17v12
  2. Study sites: 15 to 16v11
  3. Study sites: 14 to 15v10
  4. Study sites: 13 to 14v9
  5. Study sites: 11 to 13v8
  6. Study sites: 10 to 11v7
  7. Study sites: 7 to 10v6
  8. Study sites: 4 to 7v5
  9. Study sites: 3 to 4v4
  10. Study sites: 2 to 3v3
  11. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Mar 20, 2024 to Apr 4, 2024v2 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Mar 20, 2024 to Apr 4, 2024
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Significant coronary disease of the left main coronary artery (LMCA) is found in 4%-5% of all coronary angiography procedures. Classically, it has been determined that a significant angiographic stenosis should reach at least 50% of the vessel diameter by visual estimation, which corresponds to 75% of the vessel area. However, angiography has a number of limitations inherent to the technique and location of stenosis, and other techniques are therefore available for evaluation. Intracoronary ultrasound (IVUS) deserves, together with the pressure guidewire, special consideration in determining the severity assessment (anatomical and functional) of lesions in this location. Using IVUS the most commonly used cut-off value is 6 mm2. in ambiguous lesions of the LMCA, a MLA \>6 mm2 would indicate no revascularisation, a MLA \<4.5-5 mm2 would indicate revascularisation, and MLA values between 4.5-5 and 6 mm2 would make it advisable to use FRF/iFR to decide. Optical coherence tomography (OCT) is another intracoronary imaging modality, with greater resolution and significant differences from IVUS. no MLA cut-off point with OCT has been demonstrated for the management of LMCA lesions. Due to the differences in imaging with both techniques, the thresholds established as cut-off points in IVUS cannot be extrapolated to OCT. The objective is to compare the minimal luminal area by IVUS and OCT of angiographically intermediate LCMA lesions and to assess the prognostic value of TCFA assessed by OCT.
Trial Details
NCT Number NCT06272643
Lead Sponsor Fundación EPIC
Conditions Coronary Disease
Enrollment 153 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov