ILUMIEN-V - AERO: All-comEr Registry of OCT (AERO)

Myocardial Ischemia Clinical Trial

Official title: "ILUMIEN-V - AERO"- All-comEr Registry of OCT (AERO) to Investigate the MLD-MAX Algorithm for OCT-guided-precision-PCI in Daily Routine

Status Recruiting

Clinical Trial Summary

The study aims to assess contemporary practice in OCT use during routine interven-tional practice and to assess the impact of the MLD-MAX algorithm on real-world PCI in a large unselected European all-comer-study cohort.

Clinical Trial Description

Angiography is the current standard method to guide PCI strategy in clinical practice. However, angiography has a number of well-described limitations, primarily through only providing an assessment of luminal dimensions without delineation of the burden of atheroma-tous disease. Angiography also provides suboptimal assessment of post PCI complications such as stent underexpansion or malapposi-tion, residual dissections or thrombus, and tissue prolapse. These limi-tations may be overcome in part by intravascular imaging (IVI), which allows tomographic, cross-sectional imaging of the vessel wall. Meta-analyses of randomized and registry studies of IVI-guided vs. angi-ography-guided PCI have suggested that IVI-guidance may improve clinical outcome following PCI.

Optical coherence tomography (OCT) provides high-resolution (10-20 μm) cross-sectional images of plaque microarchitecture, stent place-ment and size and strut coverage. Recently the MLD-MAX algorithm was developed to guide and stand-ardize coronary stent implantation based on sizing of the vessel at the proximal and distal reference using the EEL. ;

Related Conditions & MeSH terms

• Ischemia
• Myocardial Ischemia

• NCT number: NCT05324683
• Study type: Observational [Patient Registry]
• Source: IHF GmbH - Institut für Herzinfarktforschung
• Contact: David-Manuel Leistner, Prof Dr med
• Phone: +49 30 450 513 725
• Email: David.Leistner@kgu.de
• Status: Recruiting
• Start date: May 4, 2023
• Completion date: May 30, 2025