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NCT Number: NCT07114393

Optimization of Complex Percutaneous Coronary Intervention With Liberal Use of Intracoronary Imaging Versus Contemporary Practice

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.

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Bifurcation Coronary Artery Disease Cardiovascular Diseases Chronic Total Occlusion (CTO) Coronary Artery Disease (Left Main) Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Catharina hospital Eindhoven

Eindhoven, North Brabant, 5623EJ, Netherlands

Location status: Recruiting

About this study

Design and outcomes measures will be discusses elsewhere. Additional information: Patients in this observational, registry study, will be included by the Netherlands heart registration (NHR). The NHR is an independent organization in which Dutch hospitals prospectively register standard sets of baseline, procedural and outcome data for all invasive cardiac procedures, including PCI. Data provided to the NHR are extensively checked on completeness and quality, reviewed with audit reports by independent trained research nurses and discussed by cardiologists in registration committees. Multiple audits are conducted annually by the NHR for data validation and verification. A waiver for informed consent for analysis with the data of the NHR data registry is obtained.

This study will be a quality improvement project.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Non complex PCI

Treatment and study plan

Liberal use of intracoronary imaging during complex PCI

Behavioral

A new protocol regarding use of intracoronary imaging will be implemented in multiple PCI centers in the Netherlands. Main goal of this protocol will be to increase the use of imaging in complex PCI in the Netherlands. Moreover operators will be trained according to the new protocol and on site training will be organized to improve the skills in using imaging during complex PCI.Operators are requested to use of intracoronary imaging preferentially in all complex coronary lesions, but at least increase their use with at least 50% and minimum of 25% of the cases. Throughout the second phase, individual participating operators will receive personalized feedback on their use of intracoronary imaging at multiple intervals. Based on this result, the implementation process will be refined as necessary. These intermediate measurements will also be shared with all participating centres anonymous.

Primary outcomes

  1. Occurrence of target vessel revascularization, myocardial infarction and all-cause mortality

    Time frame: 1 year

    The primary composite end point of major adverse cardiac events is the occurrence of target vessel revascularization, myocardial infarction and all-cause mortality.

Secondary outcomes

  1. Occurrence of all cause mortality

    Time frame: 30 days, 1 year

    all cause mortality, confirmed by verifying the vital status of a patient in the Personal Records Database.

  2. Occurrence of target vessel revascularization

    Time frame: 30 days and 1 year

    Target vessel revascularization, defined as a revascularization by percutaneous coronary intervention or coronary artery bypass grafting in the same vessel(s) that had been treated at the index procedure, excluding staged procedures.

  3. Occurrence of myocardial infarction

    Time frame: 30 days 1 year

    Myocardial infarction, defined as an increase and/or decrease in one or more cardiac biomarkers by at least one value above the 99th percentile of the upper limit where at least one of the following symptoms is present: 1) symptoms appropriate to ischemia, 2) new significant ST-segment or T-wave abnormalities or bundle branch block, 3) development of pathological Q-waves on the electrocardiogram (ECG), 4) imaging demonstrated new loss of viable myocardial tissue or new wall motion abnormalities, 5) identification of intracoronary thrombus on angiography or autopsy.

  4. Occurrence of stent thrombosis

    Time frame: 30 days, 1 year

    Defined as angiographically or pathologically confirmed thrombus within the stent or within 5 mm proximal or distal to the stent, occurring within 1 year, with at least one of the following criteria present within 48 hours:

    Acute onset of ischemic symptoms at rest

    New ischemic ECG changes suggestive of acute ischemia

    Characteristic rise or fall in cardiac biomarkers

    Occlusive thrombus (TIMI flow grade 0 or 1)

    Non-occlusive, visibly present thrombus (angiographically confirmed)

  5. Occurrence of target lesion revascularization

    Time frame: 30 days, 1 year

    defined as a unplanned revascularization by percutaneous coronary intervention or coronary artery bypass grafting in a lesion <5 mm distally or proximally of the lesion that had been treated at the index procedure, excluding staged procedures.

Study contacts

Contact information is provided by the study sponsor or research team.

Koen Teeuwen, MD PhD

CONTACT

[email protected]

+ 31 040 239 9111

Konrad AJ van Beek, MD

CONTACT

[email protected]

+ 31 040 239 9111

Sponsors and collaborators

Lead sponsor

Cathreine BV

Other

Collaborators

  • Abbott Medical Devices
  • Boston Scientific Corporation
  • Philips Healthcare
  • Salveo Diagnostics

Registry information

Acronym: OPTIMIZE-PCI 2

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 11, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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