Status:

RECRUITING

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

Lead Sponsor:

IHF GmbH - Institut für Herzinfarktforschung

Collaborating Sponsors:

Abbott

Conditions:

Myocardial Ischemia

Eligibility:

All Genders

18+ years

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...

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 o...

Eligibility Criteria

Inclusion

  • 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

  • none

Key Trial Info

Start Date :

May 4 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 30 2026

Estimated Enrollment :

2000 Patients enrolled

Trial Details

Trial ID

NCT05324683

Start Date

May 4 2023

End Date

January 30 2026

Last Update

May 1 2025

Active Locations (1)

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Universitätsklinikum Frankfurt - Med. Klinik 3 - Kardiologie

Frankfurt am Main, Germany, 60590