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.
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
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.
- Conditions
- Coronary Disease
- 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 group | Role | What 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.
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)
Cardiac Death
Cardiac Death
Measured: 12 months
Cardiovascular Death
Cardiovascular Death
Measured: 12 months
Acute myocardial infarction of treated/functionally assessed lesion
Acute myocardial infarction of treated/functionally assessed lesion
Measured: 12 months
Acute myocardial infarction of any lesion
Acute myocardial infarction of any lesion
Measured: 12 months
Need for revascularisation of lesion treated/functionally assessed
Need for revascularisation of lesion treated/functionally assessed
Measured: 12 months
Need for revascularisation of any lesion
Need for revascularisation of any lesion
Measured: 12 months
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
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
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.
- First posted22 Feb 2024
- Study start4 Apr 2024
- Primary completion20 Mar 2027 (estimated)
- Study completion20 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fundación EPIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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 30615155de 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 21757111Wang 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 29898668Kubo 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 24011777Kedhi 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Intermediate Left Main Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT06272643
- Acronym / sponsor ID
- EMPERATRIZ / EPIC36-EMPERATRIZ
- Conditions
- Coronary Disease
- Keywords
- Left main coronary artery, Percutaneous coronary intervention, Intravascular ultrasound, Optical coherence tomography
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Fundación EPICUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 20 Mar 2027 (estimated)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Left Main Coronary Artery lesion (25-60%) | – | Diagnostic Test: IVUS (Intravascular Ultrasound) and OCT (Optical Coherence Tomography) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVUS (Intravascular Ultrasound) and OCT (Optical Coherence Tomography)OCT and IVUS in Patients with LMCA lesion (25-60%) | Diagnostic test | Patients with Left Main Coronary Artery lesion (25-60%) |
Primary outcome
To assess the agreement between minimum luminal area measured by IVUS and OCT in intermediate LCMA lesions
Time frame: During intervention
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.
9 secondary outcomes
Cardiac Death
Time frame: 12 months
Cardiovascular Death
Time frame: 12 months
Acute myocardial infarction of treated/functionally assessed lesion
Time frame: 12 months
Acute myocardial infarction of any lesion
Time frame: 12 months
Need for revascularisation of lesion treated/functionally assessed
Time frame: 12 months
Need for revascularisation of any lesion
Time frame: 12 months
Secondary efficacy endpoint: Clear Image Length
Time frame: During intervention
Extend of detectable EEL in LM
Time frame: During intervention
Correlation between contrast volume used and results, as well as the average contrast volume used in the study.
Time frame: 30 days after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 30615155Neumann 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.
- Background: PubMed 21757111de 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.
- Background: PubMed 29898668Wang 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.
- Background: PubMed 24011777Kubo 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.
- Background: PubMed 34345911Kedhi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
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.