Registry assessing OCT use in patients with myocardial ischemia
"ILUMIEN-V - AERO"- All-comEr Registry of OCT (AERO) to Investigate the MLD-MAX Algorithm for OCT-guided-precision-PCI in Daily Routine
This study is testing whether using a special imaging technique called optical coherence tomography (OCT) during heart procedures can help improve outcomes for patients with reduced blood flow to the heart.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IHF GmbH - Institut für Herzinfarktforschung Academic / other |
| Locations | 1 site (Frankfurt am main) |
| Trial ID | NCT05324683 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the use of optical coherence tomography (OCT) in routine interventional procedures for patients with myocardial ischemia. It focuses on the impact of the MLD-MAX algorithm on percutaneous coronary intervention (PCI) outcomes in a diverse European cohort. By utilizing OCT, the study seeks to overcome the limitations of traditional angiography, which often fails to provide a comprehensive assessment of coronary artery disease and post-procedure complications. The study will gather data on patients undergoing OCT-guided evaluations to improve clinical practices in PCI.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with evidence of myocardial ischemia undergoing OCT-guided lesion evaluation.
Not a fit: Patients without evidence of myocardial ischemia or those who do not require OCT-guided evaluation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of PCI procedures for patients with myocardial ischemia.
How similar studies have performed: Previous studies have indicated that intravascular imaging, including OCT, may improve clinical outcomes compared to traditional angiography, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Patients with evidence of myocardial ischemia (e.g. stable angi-na, silent ischemia, unstable angina, or acute myocardial infarc-tion) undergoing OCT-guided lesion evaluation (OCT-scan using the devices must be performed either to guide PCI (following the MLD-MAX-algorithm) or to investigate a coronary lesion for fur-ther clinical treatment) * Written informed consent (defined as legally effective, docu-mented confirmation of a subject's (or their legally authorized representative or guardian) voluntary agreement to participate in a particular clinical study) to participate in this clinical inves-tigation Exclusion Criteria: * none
Where this trial is running
Frankfurt am main
- Universitätsklinikum Frankfurt - Med. Klinik 3 - Kardiologie — Frankfurt am main, Germany (Recruiting)
Study contacts
- Principal investigator: David-Manuel Leistner, Prof Dr med — Universitätsklinikum Frankfurt - Med. Klinik 3 - Kardiologie
- Study coordinator: David-Manuel Leistner, Prof Dr med
- Email: David.Leistner@kgu.de
- Phone: +49 30 450 513 725
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.