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

NCT06272643 | Active Not Recruiting

• 1 other identifier: EPIC36-EMPERATRIZ
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Coronary Disease

Keywords

Left main coronary artery; Percutaneous coronary intervention; Intravascular ultrasound; Optical coherence tomography

Outcome Measures

Primary Outcomes (1)

• To assess the agreement between minimum luminal area measured by IVUS and OCT in intermediate LCMA lesions

  To assess the agreement between minimum luminal area measured by IVUS and OCT in intermediate LCMA lesions in patients with PCI for MLA in ICUS \<6 mm2 and OCT without TCFA.

  During intervention

Secondary Outcomes (9)

• Cardiac Death

  12 months

• Cardiovascular Death

  12 months

• Acute myocardial infarction of treated/functionally assessed lesion

  12 months

• Acute myocardial infarction of any lesion

  12 months

• Need for revascularisation of lesion treated/functionally assessed

  12 months

Study Arms (1)

Patients with Left Main Coronary Artery lesion (25-60%)

Diagnostic Test: IVUS (Intravascular Ultrasound) and OCT (Optical Coherence Tomography)

Interventions

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

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

Patients with Left Main Coronary Artery lesion (25-60%)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (18)

Hospital General Universitari Dr Balmis

Alicante, 03010, Spain

Location

Hospital Clinico San Carlos

Aravaca, 28040, Spain

Location

Hospital Universitari Vall Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Puerta del Mar

Cadiz, 11009, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, 30120, Spain

Location

Hospital Universitario de Cabueñes

Gijón, 33394, Spain

Location

Hospital Universitario Juan Ramon Jimenez

Huelva, 21005, Spain

Location

Hospital Universitario de Jerez de La Frontera

Jerez de la Frontera, 11407, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, 08907, Spain

Location

Hospital Universitario de Leon

León, 24071, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Clínico Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, 47003, Spain

Location

Hospital Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Related Publications (5)

• Neumann FJ, Sousa-Uva M. 'Ten commandments' for the 2018 ESC/EACTS Guidelines on Myocardial Revascularization. Eur Heart J. 2019 Jan 7;40(2):79-80. doi: 10.1093/eurheartj/ehy855. No abstract available.

  PMID: 30615155 BACKGROUND

• de la Torre Hernandez JM, Hernandez Hernandez F, Alfonso F, Rumoroso JR, Lopez-Palop R, Sadaba M, Carrillo P, Rondan J, Lozano I, Ruiz Nodar JM, Baz JA, Fernandez Nofrerias E, Pajin F, Garcia Camarero T, Gutierrez H; LITRO Study Group (Spanish Working Group on Interventional Cardiology). Prospective application of pre-defined intravascular ultrasound criteria for assessment of intermediate left main coronary artery lesions results from the multicenter LITRO study. J Am Coll Cardiol. 2011 Jul 19;58(4):351-8. doi: 10.1016/j.jacc.2011.02.064.

  PMID: 21757111 BACKGROUND

• Wang Y, Mintz GS, Gu Z, Qi Y, Wang Y, Liu M, Wu X. Meta-analysis and systematic review of intravascular ultrasound versus angiography-guided drug eluting stent implantation in left main coronary disease in 4592 patients. BMC Cardiovasc Disord. 2018 Jun 14;18(1):115. doi: 10.1186/s12872-018-0843-z.

  PMID: 29898668 BACKGROUND

• Kubo T, Akasaka T, Shite J, Suzuki T, Uemura S, Yu B, Kozuma K, Kitabata H, Shinke T, Habara M, Saito Y, Hou J, Suzuki N, Zhang S. OCT compared with IVUS in a coronary lesion assessment: the OPUS-CLASS study. JACC Cardiovasc Imaging. 2013 Oct;6(10):1095-1104. doi: 10.1016/j.jcmg.2013.04.014. Epub 2013 Sep 4.

  PMID: 24011777 BACKGROUND

• Kedhi E, Berta B, Roleder T, Hermanides RS, Fabris E, IJsselmuiden AJJ, Kauer F, Alfonso F, von Birgelen C, Escaned J, Camaro C, Kennedy MW, Pereira B, Magro M, Nef H, Reith S, Al Nooryani A, Rivero F, Malinowski K, De Luca G, Garcia Garcia H, Granada JF, Wojakowski W. Thin-cap fibroatheroma predicts clinical events in diabetic patients with normal fractional flow reserve: the COMBINE OCT-FFR trial. Eur Heart J. 2021 Dec 1;42(45):4671-4679. doi: 10.1093/eurheartj/ehab433.

  PMID: 34345911 BACKGROUND

MeSH Terms

Conditions

Coronary Disease

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 22, 2024
• Study Start: April 4, 2024
• Primary Completion: March 20, 2026
• Study Completion (Estimated): April 20, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (18)