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

4. november 2026 opdateret af: IHF GmbH - Institut für Herzinfarktforschung

"ILUMIEN-V - AERO"- All-comEr Registry of OCT (AERO) for at undersøge MLD-MAX-algoritmen for OCT-guidet-præcision-PCI i daglig rutine

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1684

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
      • Frankfurt am Main, Tyskland, 60590
        • Universitätsklinikum Frankfurt - Med. Klinik 3 - Kardiologie

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Study population (cohort)

No study arms; one patient population will be observed.
Andet: No intervention planned

No intervention planned; study is observational

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stent expansion: number of participants with optimal / acceptable / unacceptable stent expansion
Tidsramme: 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 (%).
At baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Minimal Stent Area (MSA)
Tidsramme: 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
At baseline
Mean stent expansion
Tidsramme: At baseline

The mean stent area (stent volume/analyzed stent length) divided by the average of proximal and distal reference lumen areas x 100
At baseline
Intra-stent plaque protrusion and thrombus: number of major and minor protusion area / stent area
Tidsramme: 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
At baseline
Number of participants with untreated reference segmant disease
Tidsramme: 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).
At baseline
Number of participants with major and minor edge dissections
Tidsramme: 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
At baseline
Number of participants with major and minor stent malapposition
Tidsramme: 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) (%)
At baseline
Number of participants with procedural complications
Tidsramme: 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
At baseline
Number of participants with adverse events
Tidsramme: At 30 days follow-up

Target lesion failure (TLF; cardiac death, TV-MI or ischemia-driven target lesion revascularization)
At 30 days follow-up
Number of participants with adverse events
Tidsramme: At 6 months follow-up

Target lesion failure (TLF; cardiac death, TV-MI or ischemia-driven target lesion revascularization)
At 6 months follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

IHF GmbH - Institut für Herzinfarktforschung

Samarbejdspartnere

Abbott

Efterforskere

  • Ledende efterforsker: David-Manuel Leistner, Prof Dr med, Universitätsklinikum Frankfurt - Med. Klinik 3 - Kardiologie
  • Ledende efterforsker: Thomas Johnson, Dr med, Bristol Heart Institute

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. maj 2023

Primær færdiggørelse (Faktiske)

1. marts 2026

Studieafslutning (Faktiske)

1. oktober 2026

Datoer for studieregistrering

Først indsendt

6. april 2022

Først indsendt, der opfyldte QC-kriterier

6. april 2022

Først opslået (Faktiske)

12. april 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ILUMIEN-V - AERO V 1.2

Plan for individuelle deltagerdata (IPD)

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