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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Myocardial Ischemia

Intervention / Treatment
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* Other: No intervention planned


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study population (cohort)<br>No study arms; one patient population will be observed. | Other: No intervention planned<br>* No intervention planned; study is observational<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 (%). | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At baseline | 
| 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 | At baseline | 
| 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 | At baseline | 
| 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). | At baseline | 
| 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 | At baseline | 
| 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) (%) | At baseline | 
| 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 | At baseline | 
| Number of participants with adverse events | 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 | Target lesion failure (TLF; cardiac death, TV-MI or ischemia-driven target lesion revascularization) | At 6 months follow-up |