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NCT06272643: EMPERATRIZ
Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Intermediate Left Main Coronary Artery Lesions
trial testing IVUS (Intravascular Ultrasound) and OCT (Optical Coherence Tomography) in Coronary Disease in 153 participants. Participants enrolled and being followed up; not accepting new ones.
20 March 2026
Quick facts
| Lead sponsor | Fundación EPIC |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 153 |
| Start date | 4 April 2024 |
| Primary completion | 20 March 2026 |
| Estimated completion | 20 April 2026 |
| Sites | 18 locations across Spain |
Drugs / interventions tested
- IVUS (Intravascular Ultrasound) and OCT (Optical Coherence Tomography)
Conditions studied
- Coronary Disease — all drugs for Coronary Disease →
Sponsor
Fundación EPIC — full company profile →
Who can join
18 and older, any sex, with Coronary Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Coronary Intravascular Imaging: A Comprehensive Review of Techniques, Applications, and Future Directions.
Iuvara G, Franzino M, Carciotto G, De Ferrari T, et al · · 2025 · PMID 41303855 · DOI 10.3390/medicina61112019
Verify or expand the search:
- PubMed search for NCT06272643
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06272643 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundación EPIC
- Last refreshed: 13 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06272643.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing