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

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital General Universitari Dr Balmis
RECRUITING
Alicante
Hospital Clinico San Carlos
RECRUITING
Aravaca
Hospital Universitari Vall Hebron
RECRUITING
Barcelona
Hospital Universitario Puerta del Mar
RECRUITING
Cadiz
Hospital Universitario Reina Sofía
RECRUITING
Córdoba
Hospital Clínico Universitario Virgen de la Arrixaca
RECRUITING
El Palmar
Hospital Universitario de Cabueñes
RECRUITING
Gijón
Hospital Universitario Juan Ramon Jimenez
RECRUITING
Huelva
Hospital Universitario de Jerez de La Frontera
RECRUITING
Jerez De La Frontera
Hospital Universitari de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Hospital Universitario de Leon
RECRUITING
León
Hospital Universitario de La Princesa
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Clínico Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitario Marques de Valdecilla
RECRUITING
Santander
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
Hospital Clinico Universitario de Valladolid
RECRUITING
Valladolid
Hospital Universitario Lozano Blesa
RECRUITING
Zaragoza
Contact Information
Primary
SANTIAGO J CAMACHO FREIRE, MD, PhD
hemodinamica.cardiologia.huelva@gmail.com
0034677981941
Backup
FUNDACION EPIC
iepic@fundacionepic.org
0034987876135
Time Frame
Start Date: 2024-04-04
Estimated Completion Date: 2026-01-20
Participants
Target number of participants: 129
Treatments
Patients with Left Main Coronary Artery lesion (25-60%)
Related Therapeutic Areas
Sponsors
Leads: Fundación EPIC

This content was sourced from clinicaltrials.gov