Tests imaging inside coronary arteries during complex heart stent procedures
Studies heart artery imaging during complex stent procedures in adults with coronary artery disease.
Key facts
- Who runs it
- Cathreine BV
- Where
- Eindhoven, NetherlandsSee the site
- Trial code
- Registry title
- Optimization of Complex Percutaneous Coronary Intervention With Liberal Use of Intracoronary Imaging Versus Contemporary Practice
- Status
- Recruiting
- People taking part
- 11,092 people, planned
- Started
- 1 Apr 2025
- Expected to end
- 1 May 2027
- Type of study
- Observational, 2 groups
- Treatments tested
- Liberal use of intracoronary imaging during complex PCI
- Record updated
- 27 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults in the Netherlands Heart Registration who had a stent procedure (PCI) for a complex narrowing of a heart artery.
- Age
- 18 years and older
- Sex
- All sexes
- Disease stage
- Complex coronary lesions, with at least one of: left main stenosis, heavily calcified lesion, chronic total occlusion, ostial lesion, long lesion (total stent length of 38 mm or more), true bifurcation, or in-stent restenosis.
- Earlier treatment
- Must have had PCI (stent procedure) for a complex coronary lesion.
Main reasons for not taking part
- Non-complex PCI
The registry criteria, word for word
Show all 3 criteriaShow less
Who can take part
- All patients above the age of 18, included in the Netherlands Heart Registration (NHR) quality database after receiving PCI in complex coronary lesions, will be included in the analyses of this project
- Meeting one or more of the following complexity criteria:; Left main: A stenosis of >50% and/or a FFR ≤ 0.80 and iFR ≤ 0.89 in the left main; Severely calcified lesion: Defined as use of calcium modification therapy (e.g. cutting balloon, scoring balloon, rotablation, orbital atherectomy, intravascular lithotripsy); Chronic total occlusion: Coronary CTO is defined as an obstruction of the coronary artery with the following classic lesion characteristics:; TIMI flow 0; Absence of contrast stasis at the site of the proximal capillaries; Presence of collateral vessels; Estimated occlusion duration of at least 3 months; Ostial lesion: Lesion at the origin (within 5 mm) of a major coronary vessel (LM, LAD, RCX and RCA); Long lesion: A vessel treated with one or multiple stents with a total stent length of ≥38 mm is considered a long lesion; Bifurcation (true): A coronary artery narrowing occurring adjacent to, and/or involving, the origin of a significant side branch ≥ 2.5mm. Only true bifurcation will be included, i.e. medina 1,1,1/1,0,1/0,1,1; In-stent restenosis: A reduction ≥50% of the luminal diameter within the previously stented segment or the vessel segments 5 mm proximal and distal to the stent (the "stent edges"), as assessed by coronary angiography
Who cannot take part
- Non complex PCI
Where in Netherlands
- Catharina Hospital EindhovenEindhoven, NetherlandsContact: Koen Teeuwen, MD PhDTaking people
About the trial
What the trial wants to find out
Coronary artery disease remains a leading cause of mortality worldwide and is commonly treated with percutaneous coronary intervention (PCI). Typically, PCI is guided by invasive coronary angiography (ICA). However, ICA has inherent limitations in accurately assessing vessel dimensions, calcium burden, circumferential tissue and whether a stent has achieved full expansion. Therefore ICA alone is insufficient for guiding stent optimization, especially in complex lesions which are most vulnerable to long-term stent failure. To overcome the limitations of ICA, intracoronary imaging can be used to guide and optimize PCI. The advantages of intracoronary imaging include obtaining larger lumen areas, better stent expansion and strut apposition, full lesion stent coverage and identifying stent complications. Multiple randomized studies have shown that these advantages translate into a reduction in major adverse cardiovascular events (MACE) in complex PCI. Consequently, the recommendation for intracoronary imaging has been upgraded in the most recent guidelines.
Read full original descriptionShow less
Despite robust evidence supporting its benefits, intracoronary imaging remains relatively underused in real-world practice and in the Netherlands it is only used in 7% of complex PCI procedures. This underutilization may be attributed to several factors, including operator and hospital-dependent issues such as lack of experience, reluctance to spend additional time on intracoronary imaging and concerns about its cost-effectiveness. Therefore, initiating an implementation project to incorporate intracoronary imaging into routine use in the catheterization lab during complex PCI would be highly valuable. Such a project could make imaging-guided PCI the standard of care in complex PCI. Additionally, it could evaluate the cost-effectiveness of routine intracoronary imaging during complex PCI.
For this reason we designed the OPTIMIZE-PCI II, a national registry-based quality improvement project. This project is aimed at implementing a liberal intracoronary imaging-guided strategy for complex PCI across multiple centres in the Netherlands, with data extraction from the Netherlands Heart Registration (NHR) database. The objective of the OPTIMIZE-PCI II is to establish a routine use of intracoronary imaging in complex PCI, to determine if this approach reduces adverse cardiac events in real-world practice, and evaluate its cost-effectiveness.
The 2 groups in the trial
- Pre-implementation cohort
This group will serve as the control cohort before implementation of a new intracoronary imaging protocol. Data from the national PCI registry, which will be supplemented with an additional set of procedural variables. Data on the percentage of use of intracoronary imaging in complex coronary lesions by the individual interventional cardiologist will be collected. This will establish a benchmark from which individual interventional cardiologists must increase their use of intracoronary imaging. This will be the pre-implementation cohort that will be used as the comparator in the final evaluation.
- Post-implementation cohort
This is the cohort in which a new intracoronary imaging protocol will be implemented. Main goal of this protocol is the increase the use of intracoronary imaging during complex PCI in the Netherlands. The duration of this phase will be approximately 1-2 year.
Treatment: Liberal use of intracoronary imaging during complex PCI
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Optimization of Complex Percutaneous Coronary Intervention With Liberal Use of Intracoronary Imaging Versus Contemporary Practice
- Plain-language title
- Tests imaging inside coronary arteries during complex heart stent proceduresGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 27 March 2026