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NCT05324683 | RECRUITING | Myocardial Ischemia

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

IHF GmbH - Institute for Heart Infarction Research

Brief 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.

Condition or disease

Myocardial Ischemia

Intervention/treatment

No intervention planned

Detailed 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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 2000 participants
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
Actual Study Start Date : 2023-05-04
Estimated Primary Completion Date : 2024-10-30
Estimated Study Completion Date : 2025-05-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
ILUMIEN-V - AERO: All-comEr Registry of OCT (AERO)

Location Details

NCT05324683

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Germany,

University Hospital Frankfurt - Med. Clinic 3 - Cardiology

Frankfurt am main, Germany, 60590