Clinical trial NCT05324683: ILUMIEN-V - AERO: All-comEr Registry of OCT (AERO)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Ischemia
Lead sponsor: IHF GmbH - Institut für Herzinfarktforschung
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2022-04-12
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stent expansion: number of participants with optimal / acceptable / unacceptable stent expansion
timeFrame: At baseline
Secondary outcomes:
measure: Minimal Stent Area (MSA)
timeFrame: At baseline
measure: Mean stent expansion
timeFrame: At baseline
measure: Intra-stent plaque protrusion and thrombus: number of major and minor protusion area / stent area
timeFrame: At baseline
measure: Number of participants with untreated reference segmant disease
timeFrame: At baseline
measure: Number of participants with major and minor edge dissections
timeFrame: At baseline
measure: Number of participants with major and minor stent malapposition
timeFrame: At baseline
measure: Number of participants with procedural complications
timeFrame: At baseline
measure: Number of participants with adverse events
timeFrame: At 30 days follow-up
measure: Number of participants with adverse events
timeFrame: At 6 months follow-up
Other outcomes:
Locations:
city: Frankfurt am main
country: Germany
facility: Universitätsklinikum Frankfurt - Med. Klinik 3 - Kardiologie
Study officials:
affiliation: Universitätsklinikum Frankfurt - Med. Klinik 3 - Kardiologie
name: David-Manuel Leistner, Prof Dr med
role: PRINCIPAL_INVESTIGATOR
affiliation: Bristol Heart Institute
name: Thomas Johnson, Dr med
role: PRINCIPAL_INVESTIGATOR
References: