Comparing imaging techniques for coronary artery lesions
Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Intermediate Left Main Coronary Artery Lesions
This study is testing whether two different imaging techniques, Optical Coherence Tomography and Intravascular Ultrasound, can better help doctors understand and treat patients with certain types of coronary artery blockages.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 129 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación EPIC Academic / other |
| Locations | 17 sites (Alicante and 16 other locations) |
| Trial ID | NCT06272643 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the effectiveness of Optical Coherence Tomography (OCT) and Intravascular Ultrasound (IVUS) in assessing intermediate lesions in the left main coronary artery (LMCA). The study focuses on patients with 25-60% angiographic stenosis, evaluating the anatomical and functional severity of lesions to guide treatment decisions. By utilizing both imaging techniques, the study seeks to improve the accuracy of coronary disease assessments and potentially enhance patient outcomes. Participants will undergo both IVUS and OCT imaging to determine the best approach for managing their coronary artery disease.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 and older with intermediate lesions in the LMCA and who can provide informed consent.
Not a fit: Patients with indications for coronary surgery or those with acute coronary syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate assessments of coronary artery lesions, improving treatment decisions and patient outcomes.
How similar studies have performed: Previous studies have shown varying success with similar imaging techniques, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Alicante and 16 other locations
- Hospital General Universitari Dr Balmis — Alicante, Spain (Recruiting)
- Hospital Clinico San Carlos — Aravaca, Spain (Recruiting)
- Hospital Universitari Vall Hebron — Barcelona, Spain (Recruiting)
- Hospital Universitario Puerta del Mar — Cadiz, Spain (Recruiting)
- Hospital Universitario Reina Sofía — Córdoba, Spain (Recruiting)
- Hospital Clínico Universitario Virgen de la Arrixaca — El Palmar, Spain (Recruiting)
- Hospital Universitario de Cabueñes — Gijón, Spain (Recruiting)
- Hospital Universitari de Bellvitge — Hospitalet de Llobregat, Spain (Recruiting)
- Hospital Universitario Juan Ramon Jimenez — Huelva, Spain (Recruiting)
- Hospital Universitario de Jerez de La Frontera — Jerez De La Frontera, Spain (Recruiting)
- Hospital Universitario de Leon — León, Spain (Recruiting)
- Hospital Universitario La Paz — Madrid, Spain (Recruiting)
- Hospital Clínico Universitario de Salamanca — Salamanca, Spain (Recruiting)
- Hospital Universitario Marques de Valdecilla — Santander, Spain (Recruiting)
- Hospital Universitario Virgen Del Rocio — Sevilla, Spain (Recruiting)
- Hospital Clinico Universitario de Valladolid — Valladolid, Spain (Recruiting)
- Hospital Universitario Lozano Blesa — Zaragoza, Spain (Recruiting)
Study contacts
- Study coordinator: SANTIAGO J CAMACHO FREIRE, MD, PhD
- Email: hemodinamica.cardiologia.huelva@gmail.com
- Phone: 0034677981941
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.