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ACTIVE NOT RECRUITING
NCT06272643

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

Sponsor: Fundación EPIC

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

153

Start Date

2024-04-04

Completion Date

2026-04-20

Last Updated

2026-02-13

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

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

OCT and IVUS in Patients with LMCA lesion (25-60%)

Locations (18)

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