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NCT06272643Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 9 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
153 (actual)
First submitted
1 Feb 2024
Start date
4 Apr 2024
Primary completion date
20 Mar 2027
Lead sponsor
Fundación EPIC
NCT number
NCT06272643

What you commit to

  • Study type: Observational
  • Participants enrolled: 153
  • From 4 Apr 2024 to the primary completion date, 20 Mar 2027
  • 18 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with indication for coronary surgery regardless of significance of LMCA lesion.
  • Patients with lesion in a previous functioning arterial or venous graft in the territory supplied by the LMCA (protected LMCA).

Other illness

  • Patients with acute coronary syndrome with potentially culpable injury in LMCA.

Other

  • Patients with LMCA lesion showing ulceration, dissection or thrombus.
  • Patients unable to give informed consent.
  • Patients with ostial LMCA lesion.

Who the study is looking for

  • Patients aged ≥18 years
  • Patients with intermediate lesion in the LMCA (Left Main Coronary Artery) (25-60% angiographic stenosis by visual estimation) in whom a study with intracoronary imaging technique is considered (at least one pullback with IVUS (Intravascular ultrasound) and OCT (OPTICAL COHERENCE TOMOGRAPHY) from one of the main branches is mandatory).
  • Patients able to give informed consent form.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (18)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital General Universitari Dr Balmis
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AlicanteSpainUnknown status
Hospital Clínico San Carlos
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AravacaSpainUnknown status
Hospital Universitari Vall Hebron
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BarcelonaSpainUnknown status
Hospital Universitario Puerta del Mar
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CadizSpainUnknown status
Hospital Universitario Reina Sofia
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CórdobaSpainUnknown status
Hospital Clínico Universitario Virgen de la Arrixaca
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El PalmarSpainUnknown status
Hospital Universitario de Cabueñes
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GijónSpainUnknown status
Hospital Universitario Juan Ramon Jimenez
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HuelvaSpainUnknown status
Hospital Universitario de Jerez de La Frontera
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Jerez de la FronteraSpainUnknown status
Hospital Universitario De Leon
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LeónSpainUnknown status
Hospital Universitari de Bellvitge
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L'Hospitalet de LlobregatSpainUnknown status
Hospital Universitario de la Princesa
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MadridSpainUnknown status
Hospital Universitario La Paz
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MadridSpainUnknown status
Hospital Clinico Universitario de Salamanca
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SalamancaSpainUnknown status
Hospital Universitario Marqués de Valdecilla
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SantanderSpainUnknown status
Hospital Universitario Virgen del Rocio
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SevilleSpainUnknown status
Hospital Clínico Universitario de Valladolid
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ValladolidSpainUnknown status
Hospital Universitario Lozano Blesa
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ZaragozaSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.