ILUMIEN V - AERO
Research type
Research Study
Full title
All-comEr Registry of OCT (AERO) to investigate the MLD-MAX algorithm for OCT-guided-precision-PCI in daily routine
IRAS ID
318121
Contact name
Thomas Johnson
Contact email
Sponsor organisation
IHF GmbH
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
The ILUMIEN-V – AERO study is a prospective, non-interventional, single-arm, open-label, international multicentre registry study involving about 25 sites (Germany: 10; UK: 10; Saudi Arabia: 5). It is planned to include 2,000 patients with myocardial ischaemia (lack of oxygen rich blood supply to the heart muscle) who undergo optical coherence tomography (OCT) assessment. OCT assessment involves feeding an infrared emitting catheter into the heart blood vessel (coronary artery) itself. Optical coherence tomography (OCT) provides high-resolution (10-20 microns) cross-sectional images of the diseased section of the coronary artery. It also helps with dimensional assessment of the vessel, extent of disease and assessing for optimal expansion and complications after percutaneous coronary intervention (PCI) – this entails treatment of the coronary artery with a balloon or stent.
Recently the MLD-MAX (morphology, length, diameter, medial dissection, apposition, expansion) algorithm was developed to guide and standardise coronary stent implantation.
We want to assess the impact of the MLD-MAX algorithm in OCT use on real-world PCI in a large, unselected cohort. We also want to test if the engagement with the MLD-MAX algorithmic approach for OCT-guided PCI in this study is better than angiography-only-guided PCI-approach in the control arm of ILUMIEN-IV-Optimize-PCI trial. We expect at least 50% of our cohort to match the inclusion criteria of the ILUMIEN IV trial to allow for this comparison.
Patients will be consented retrospectively as this is part of standard practice. A total study duration of 18 months is assumed, of which about 12 months account for enrolment and 6 months for the follow-up.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
23/SC/0186
Date of REC Opinion
20 Jun 2023
REC opinion
Favourable Opinion