ILUMIEN-V - AERO: Registro All-comEr dell'OCT (AERO)
"ILUMIEN-V - AERO" - Registro All-comEr di OCT (AERO) per indagare sull'algoritmo MLD-MAX per PCI di precisione guidata da OCT nella routine quotidiana
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Frankfurt am Main, Germania, 60590
- Universitätsklinikum Frankfurt - Med. Klinik 3 - Kardiologie
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Patients with evidence of myocardial ischemia (e.g. stable angina, silent ischemia, unstable angina, or acute myocardial infarction) un-dergoing OCT-guided lesion evaluation.
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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Study population (cohort)
No study arms; one patient population will be observed. |
No intervention planned; study is observational |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Stent expansion: number of participants with optimal / acceptable / unacceptable stent expansion
Lasso di tempo: At baseline
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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Minimal Stent Area (MSA)
Lasso di tempo: At baseline
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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
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Mean stent expansion
Lasso di tempo: At baseline
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The mean stent area (stent volume/analyzed stent length) divided by the average of proximal and distal reference lumen areas x 100 |
At baseline
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Intra-stent plaque protrusion and thrombus: number of major and minor protusion area / stent area
Lasso di tempo: At baseline
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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:
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At baseline
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Number of participants with untreated reference segmant disease
Lasso di tempo: At baseline
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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
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Number of participants with major and minor edge dissections
Lasso di tempo: At baseline
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Edge dissections will be tabulated as:
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At baseline
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Number of participants with major and minor stent malapposition
Lasso di tempo: At baseline
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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:
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At baseline
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Number of participants with procedural complications
Lasso di tempo: At baseline
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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
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Number of participants with adverse events
Lasso di tempo: At 30 days follow-up
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Target lesion failure (TLF; cardiac death, TV-MI or ischemia-driven target lesion revascularization) |
At 30 days follow-up
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Number of participants with adverse events
Lasso di tempo: At 6 months follow-up
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Target lesion failure (TLF; cardiac death, TV-MI or ischemia-driven target lesion revascularization) |
At 6 months follow-up
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: David-Manuel Leistner, Prof Dr med, Universitätsklinikum Frankfurt - Med. Klinik 3 - Kardiologie
- Investigatore principale: Thomas Johnson, Dr med, Bristol Heart Institute
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ILUMIEN-V - AERO V 1.2
Piano per i dati dei singoli partecipanti (IPD)
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