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

NCT05324683 | Active Not Recruiting

• 1 other identifier: ILUMIEN-V - AERO V 1.2
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Ischemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Minimal Stent Area (MSA)

  At baseline

• Mean stent expansion

  At baseline

• Intra-stent plaque protrusion and thrombus: number of major and minor protusion area / stent area

  At baseline

• Number of participants with untreated reference segmant disease

  At baseline

• Number of participants with major and minor edge dissections

  At baseline

Study Arms (1)

Study population (cohort)

No study arms; one patient population will be observed.

Other: No intervention planned

Interventions

No intervention planned OTHER

No intervention planned; study is observational

Study population (cohort)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• IHF GmbH - Institut für Herzinfarktforschung: lead
• Abbott: collaborator

Study Sites (1)

Universitätsklinikum Frankfurt - Med. Klinik 3 - Kardiologie

Frankfurt am Main, 60590, Germany

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• David-Manuel Leistner, Prof Dr med

  Universitätsklinikum Frankfurt - Med. Klinik 3 - Kardiologie

  PRINCIPAL INVESTIGATOR

• Thomas Johnson, Dr med

  Bristol Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 12, 2022
• Study Start: May 4, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)