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Myocardial IschemiaNCT05324683

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

An observational study of Myocardial Ischemia, run by IHF GmbH - Institut für Herzinfarktforschung at 1 site in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Ischemia
How many people
2,000 participants
Where
1 siteGermany
Study dates
4 May 2023to Apr 2026
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with evidence of myocardial ischemia (e.g. stable angina, silent ischemia, unstable angina, or acute myocardial infarction) un-dergoing OCT-guided lesion evaluation.

Who may be able to join

  • 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

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Universitätsklinikum Frankfurt - Med. Klinik 3 - Kardiologie

    Frankfurt am Main, 60590

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
No intervention planned
Medical subject headings
Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No intervention plannedOther

    No intervention planned; study is observational

Study groups in NCT05324683
Study groupRoleWhat they receive
Study population (cohort)No study arms; one patient population will be observed.
Receives: Other: No intervention planned

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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 (%).

    Measured: At baseline

Secondary outcomes (9)

  1. Minimal Stent Area (MSA)

    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

    Measured: At baseline

  2. Mean stent expansion

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

    Measured: At baseline

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

    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

    Measured: At baseline

  4. Number of participants with untreated reference segmant disease

    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).

    Measured: At baseline

  5. Number of participants with major and minor edge dissections

    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

    Measured: At baseline

  6. Number of participants with major and minor stent malapposition

    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) (%)

    Measured: At baseline

  7. Number of participants with procedural complications

    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

    Measured: At baseline

  8. Number of participants with adverse events

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

    Measured: At 30 days follow-up

  9. Number of participants with adverse events

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

    Measured: At 6 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2022
  2. Study start4 May 2023
  3. Primary completionApr 2026 (estimated)
  4. Study completionApr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05324683
Sponsor's protocol ID
ILUMIEN-V - AERO V 1.2
Status last verified
Mar 2026
First submitted
6 Apr 2022
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Ischemia, run by IHF GmbH - Institut für Herzinfarktforschung at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stent expansion: number of participants with optimal / acceptable / unacceptable stent expansion (time frame: At baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05324683.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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