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

Last updated: March 5, 2024
Sponsor: IHF GmbH - Institut für Herzinfarktforschung
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myocardial Ischemia

Occlusions

Chest Pain

Treatment

No intervention planned

Clinical Study ID

NCT05324683
ILUMIEN-V - AERO V 1.2
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 lesionevaluation (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-therclinical treatment)
  • Written informed consent (defined as legally effective, docu-mented confirmation of asubject's (or their legally authorized representative or guardian) voluntary agreementto participate in a particular clinical study) to participate in this clinicalinves-tigation

Exclusion

Exclusion Criteria:

  • none

Study Design

Total Participants: 2000
Treatment Group(s): 1
Primary Treatment: No intervention planned
Phase:
Study Start date:
May 04, 2023
Estimated Completion Date:
May 30, 2025

Study 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.

Connect with a study center

  • Universitätsklinikum Frankfurt - Med. Klinik 3 - Kardiologie

    Frankfurt am main, 60590
    Germany

    Active - Recruiting

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