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Clinical Trials in Spain / NCT06272643
Active, not recruiting Observational

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

NCT06272643 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2024-04-04
Last updated
2026-02-13

Condition(s) studied

Coronary Disease

Investigational drug(s) / intervention(s)

IVUS (Intravascular Ultrasound) and OCT (Optical Coherence Tomography)

IVUS (Intravascular Ultrasound) and OCT (Optical Coherence Tomography): OCT and IVUS in Patients with LMCA lesion (25-60%)

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * Patients with indication for coronary surgery regardless of significance of LMCA lesion. * Patients with LMCA lesion showing ulceration, dissection or thrombus. * Patients with lesion in a previous functioning arterial or venous graft in the territory supplied by the LMCA (protected LMCA). * Patients with acute coronary syndrome with potentially culpable injury in LMCA. * Patients unable to give informed consent. * Patients with ostial LMCA lesion.

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
Hospital General Universitari Dr Balmis Alicante Spain
Hospital Clinico San Carlos Aravaca Spain
Hospital Universitari Vall Hebron Barcelona Spain
Hospital Universitario Puerta del Mar Cadiz Spain
Hospital Universitario Reina Sofía Córdoba Spain
Hospital Clínico Universitario Virgen de la Arrixaca El Palmar Spain
Hospital Universitario de Cabueñes Gijón Spain
Hospital Universitario Juan Ramon Jimenez Huelva Spain
Hospital Universitario de Jerez de La Frontera Jerez de la Frontera Spain
Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Spain
Hospital Universitario de Leon León Spain
Hospital Universitario de La Princesa Madrid Spain
Hospital Universitario La Paz Madrid Spain
Hospital Clínico Universitario de Salamanca Salamanca Spain
Hospital Universitario Marques de Valdecilla Santander Spain
Hospital Universitario Virgen Del Rocio Seville Spain
Hospital Clinico Universitario de Valladolid Valladolid Spain
Hospital Universitario Lozano Blesa Zaragoza Spain

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06272643 on ClinicalTrials.gov ↗ ← All trials in Spain