Trials / Active Not Recruiting
Active Not RecruitingNCT05324683
ILUMIEN-V - AERO: All-comEr Registry of OCT (AERO)
"ILUMIEN-V - AERO"- All-comEr Registry of OCT (AERO) to Investigate the MLD-MAX Algorithm for OCT-guided-precision-PCI in Daily Routine
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,000 (estimated)
- Sponsor
- IHF GmbH - Institut für Herzinfarktforschung · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No intervention planned | No intervention planned; study is observational |
Timeline
- Start date
- 2023-05-04
- Primary completion
- 2026-04-01
- Completion
- 2026-04-01
- First posted
- 2022-04-12
- Last updated
- 2026-03-27
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT05324683. Inclusion in this directory is not an endorsement.