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NCT Number: NCT05324683

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Myocardial Ischemia Cardiovascular Diseases Heart Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Frankfurt - Med. Klinik 3 - Kardiologie

Frankfurt am Main, 60590, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention planned

Other

No intervention planned; study is observational

Primary outcomes

  1. Stent expansion: number of participants with optimal / acceptable / unacceptable stent expansion

    Time frame: At baseline

    Stent expansion is defined by the MSA achieved in the proximal and distal stented segments relative to their respective reference lumen areas. Stent expansion will be categorised as follows:

    Optimal stent expansion (y/n); acceptable stent expansion (y/n); unacceptable stent expansion (y/n); post-PCI stent expansion (%).

Secondary outcomes

  1. Minimal Stent Area (MSA)

    Time frame: At baseline

    Imaging Outcome: minimal stent area as continuous measure; Final Post-PCI MSA (per target lesion basis) assessed by final-OCT after PCI; measured at an independent OCT core laboratory. Imaging-Outcome: Minimal-Stent-Area (MSA), continuous measure

  2. Mean stent expansion

    Time frame: At baseline

    The mean stent area (stent volume/analyzed stent length) divided by the average of proximal and distal reference lumen areas x 100

  3. Intra-stent plaque protrusion and thrombus: number of major and minor protusion area / stent area

    Time frame: At baseline

    Defined as a mass attached to the luminal surface or floating within the lumen, meeting the following criteria: Protrusion/thrombus is defined as any intraluminal mass protruding at least 0.2 mm within the luminal edge of a stent strut, and will be further classified as Major and Minor:

    • Major: Protrusion area/Stent area at site of tissue protrusion ≥10% and the minimal intra-stent flow area (MSA - protrusion area) is unacceptable (<90% of respective proximal or distal reference area
    • Minor: Protrusion area/Stent area at site of tissue protrusion is <10%, or is ≥10% but the minimal intraluminal flow area (MSA - protrusion area) is acceptable (≥90% of respective proximal or distal reference area

  4. Number of participants with untreated reference segmant disease

    Time frame: At baseline

    Defined as focal disease with untreated MLA <4.5 mm2 within 5 mm from the proximal and/or distal stent edges. Sub-classified by the amount of untreated lipid plaque, divided into 3 grades: Low (≤90° of lipid arc), Medium (>90°-<180° of lipid arc) and High (≥180° of lipid arc).

  5. Number of participants with major and minor edge dissections

    Time frame: At baseline

    Edge dissections will be tabulated as:

    • Major (%): ≥60 degrees of the circumference of the vessel at site of dissection and ≥3 mm in length
    • Minor (%): any visible edge dissection <60 degrees of the cir-cumference of the vessel or <3 mm in length

  6. Number of participants with major and minor stent malapposition

    Time frame: At baseline

    Defined as frequency (%) of incompletely apposed stent struts (defined as stent struts clearly separated from the vessel wall (lumen bor-der/plaque surface) without any tissue behind the struts with a distance from the adjacent intima of ≥0.2 mm and not associated with any side branch). Malapposition will be further classified as:

    • Major: if associated with unacceptable stent expansion (as de-fined above)
    • Minor: if associated with acceptable stent expansion (as defined above) Stent Malapposition will be tabulated as: Major (%); Minor (%); All (Major and Minor) (%)

  7. Number of participants with procedural complications

    Time frame: At baseline

    Defined as prolonged ST-segment elevation or depression (>30 minutes), cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemody-namic support or intubation or procedural death

  8. Number of participants with adverse events

    Time frame: At 30 days follow-up

    Target lesion failure (TLF; cardiac death, TV-MI or ischemia-driven target lesion revascularization)

  9. Number of participants with adverse events

    Time frame: At 6 months follow-up

    Target lesion failure (TLF; cardiac death, TV-MI or ischemia-driven target lesion revascularization)

Sponsors and collaborators

Lead sponsor

IHF GmbH - Institut für Herzinfarktforschung

Other

Collaborators

  • Abbott

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 12, 2022
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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