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

Myocardial Ischemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05324683
• Other study ID #: ILUMIEN-V - AERO V 1.2
• Status: Recruiting
• Start date: May 4, 2023
• Est. completion date: May 30, 2025

Study information

• Verified date: May 2023
• Source: IHF GmbH - Institut für Herzinfarktforschung
• Contact: David-Manuel Leistner, Prof Dr med
• Phone: +49 30 450 513 725
• Email: David.Leistner[@]kgu.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: May 30, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Myocardial Ischemia

Intervention

Other:
• No intervention planned
No intervention planned; study is observational

Locations

Country	Name	City	State
Germany	Universitätsklinikum Frankfurt - Med. Klinik 3 - Kardiologie	Frankfurt am main

Sponsors (2)

Lead Sponsor	Collaborator
IHF GmbH - Institut für Herzinfarktforschung	Abbott

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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