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AzTrials

Coronary DiseaseEMPERATRIZNCT06272643

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

An observational study of Coronary Disease, run by Fundación EPIC at 18 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Disease
What is being tested?
IVUS (Intravascular Ultrasound) and OCT (Optical Coherence Tomography)
How many people
153 participants
Where
18 sitesSpain
Study dates
4 Apr 2024to 20 Mar 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Spain18 sites
  • Hospital General Universitari Dr Balmis

    Alicante, 03010

  • Hospital Clinico San Carlos

    Aravaca, 28040

  • Hospital Universitari Vall Hebron

    Barcelona, 08035

  • Hospital Universitario Puerta del Mar

    Cadiz, 11009

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar, 30120

  • Hospital Universitario de Cabueñes

    Gijón, 33394

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, 21005

  • Hospital Universitario de Jerez de La Frontera

    Jerez de la Frontera, 11407

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, 08907

  • Hospital Universitario de Leon

    León, 24071

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Clínico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47003

  • Hospital Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

About this study

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.

Read the detailed description

Significant coronary disease of the left main coronary artery (LMCA) is found in 4%-5% of all coronary angiography procedures. It is a particularly important site, since it supplies up to 75% of myocardial blood supply, and damage at this level thus implies a large amount of left ventricular myocardium at risk, with a mortality rate close to 40% at 3 years, if revascularisation is not performed.

Anatomically, it has a number of particularities compared to the rest of the coronary arteries, such as its larger diameter (5±0.5 mm) and variable length (10.5±5.3 mm), a composition, particularly at the aorto-ostial level, more similar to the aorta than to the coronary arteries, and in up to 20-30% of the population there is also a division between the anterior descending artery (LAD) and the circumflex artery (LCx) of a third branch called the ramus intermedius or bisector branch.

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 (ICUS or IVUS) deserves, together with the pressure guidewire, special consideration in determining the severity assessment (anatomical and functional) of lesions in this location.

Several ICUV studies have attempted to find a minimum luminal area (MLA) as the cut-off point, ranging from 4.5-7.5 mm2, to decide whether to perform revascularisation or not. However, the most commonly used cut-off value is 6 mm2 for various reasons. First, it is correlated with functionally significant values using pressure guidewire. Second, the linear law is applied (assuming the fractal nature of the vasculature and a cut-off value of 3 mm2 for the LMCA branches). Finally, it has been validated by the prospective LITRE study with clinical results at 2 years of follow-up. Other studies in Asian population have proposed lower cut-off values (4.5 mm2). However, this population has different body size and therefore smaller LMCA size, the study has lower sensitivity (1/4 of patients with area >4.5 mm2 had positive pressure guidewire), and clinical validation is not presented unlike the LITRE study.

In addition to its value in diagnosis, use of ICUSE allows for optimisation of percutaneous coronary intervention (PCI) if necessary, with decreased events as compared to angiography. Therefore, current clinical practice guidelines consider the use of IVUS to stratify the severity of all LMCA lesions as an indication IIa B. In turn, it has been proposed to integrate the use of ICUS and pressure guidewire in the assessment of doubtful LMCA lesions. Thus, 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 ICUS. It is an expanding technique. However, its usefulness in LMCA is somewhat more limited, mainly due to the difficult technique of complete filling with contrast and the native area of the ostial segments. Another disadvantage of its use in LMCA is its limited penetration depth (2-3 mm) compared to ICUS (4-8 mm), and since the LMCA usually has diameters of 3.5-4.5 mm, inadequate assessment may occur. In addition, no MLA cut-off point with OCT has been demonstrated for the management of LMCA lesions. On the other hand, because of the differences in imaging with both techniques, the thresholds established as cut-off points in IVUS cannot be extrapolated to OCT. There are, however, some correlation studies between ICUS and OCT, both in vivo and in vitro, but not specifically in LMCA. In all these studies, it has been shown that ICUS consistently overestimates OCT measurement by ≈10%, the latter being the closest to the real value. The underuse of this technique in the LCMA is justified by the potential technical problems already mentioned and the lack of a validated MLA cut-off point at this level. The potential prognostic implication of finding, even in patients with functionally nonsignificant lesions, vulnerable plaques or thin-cap fibroatheromas (TCFAs) in OCT has recently been highlighted. The objective is to compare the minimal luminal area by ICUS and OCT of angiographically intermediate LCMA lesions and to assess the prognostic value of TCFA assessed by OCT.

Being tested
IVUS (Intravascular Ultrasound) and OCT (Optical Coherence Tomography)
Keywords
Left main coronary artery, Percutaneous coronary intervention, Intravascular ultrasound, Optical coherence tomography
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IVUS (Intravascular Ultrasound) and OCT (Optical Coherence Tomography)Diagnostic test

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

Study groups in NCT06272643
Study groupRoleWhat they receive
Patients with Left Main Coronary Artery lesion (25-60%)Not described
Receives: Diagnostic Test: IVUS (Intravascular Ultrasound) and OCT (Optical Coherence Tomography)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: During intervention

Secondary outcomes (9)
  1. Cardiac Death

    Cardiac Death

    Measured: 12 months

  2. Cardiovascular Death

    Cardiovascular Death

    Measured: 12 months

  3. Acute myocardial infarction of treated/functionally assessed lesion

    Acute myocardial infarction of treated/functionally assessed lesion

    Measured: 12 months

  4. Acute myocardial infarction of any lesion

    Acute myocardial infarction of any lesion

    Measured: 12 months

  5. Need for revascularisation of lesion treated/functionally assessed

    Need for revascularisation of lesion treated/functionally assessed

    Measured: 12 months

  6. Need for revascularisation of any lesion

    Need for revascularisation of any lesion

    Measured: 12 months

  7. Secondary efficacy endpoint: Clear Image Length

    The cumulative length of the OCT pullback containing clear cross-sectional image frames according to the measures used for OCT approval. Corelab Ultreon.

    Measured: During intervention

  8. Extend of detectable EEL in LM

    To measure the extend of detectable external elastic lamina (EEL) in left main artery (LM) with the corelab ultreon software, defined by length in mm and circunferencial grades (up to 360º) of EEL

    Measured: During intervention

  9. Correlation between contrast volume used and results, as well as the average contrast volume used in the study.

    Correlation between contrast flow and total volume used and results, as well as the average contrast volume used in the study. The contrast flow and total volume would be expresed in ml/sec and ml respectively, and results will be determinated in the corelab with the ultreon software as interpretable images or not interpretable images. The average contrast volume in ml, will be correlated with the incidence of contrast induced nephropathy defined as the impairment of kidney function-measured as either a 25% increase in serum creatinine (SCr) from baseline or a 0.5 mg/dL (44 µmol/L) increase in absolute SCr value-within 48-72 hours after intravenous contrast administration.

    Measured: 30 days after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2024
  2. Study start4 Apr 2024
  3. Primary completion20 Mar 2027 (estimated)
  4. Study completion20 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06272643
Sponsor's protocol ID
EPIC36-EMPERATRIZ
Acronym
EMPERATRIZ
Status last verified
Oct 2026
First submitted
1 Feb 2024
Last updated
9 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30615155
  • 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.

    PubMed 21757111
  • 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.

    PubMed 29898668
  • 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.

    PubMed 24011777
  • 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.

    PubMed 34345911

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Disease, run by Fundación EPIC at 18 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the agreement between minimum luminal area measured by IVUS and OCT in intermediate LCMA lesions (time frame: During intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06272643, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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