Coronary Artery DiseaseOPTIMIZE-PCI 2NCT07114393
Optimization of Complex Percutaneous Coronary Intervention With Liberal Use of Intracoronary Imaging Versus Contemporary Practice
An observational study of Coronary Artery Disease and Coronary Artery Disease (Left Main), run by Cathreine BV at 1 site in Netherlands.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Disease (Left Main), Chronic Total Occlusion (CTO)
- What is being tested?
- Liberal use of intracoronary imaging during complex PCI
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 11,092 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2025to 1 May 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population exists of patients registered in our national PCI registration of the Netherlands Heart Registration after receiving complex PCI. All indications are included (ACS and non-ACS, OHCA, cardiogenic shock).
Who may be able to join
- 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
Show all 13Show fewer
- 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 join
- Non complex PCI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Catharina hospital Eindhoven
Eindhoven, North Brabant, 5623EJ
About this study
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.
Read the detailed description
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.
- Conditions
- Coronary Artery Disease, Coronary Artery Disease (Left Main), Chronic Total Occlusion (CTO), Bifurcation Coronary Artery Disease
- Being tested
- Liberal use of intracoronary imaging during complex PCI
- Keywords
- percutaneous coronary intervention, intracoronary imaging, stent optimization, complex coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberal use of intracoronary imaging during complex PCIBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Liberal use of intracoronary imaging during complex PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of target vessel revascularization, myocardial infarction and all-cause mortality
The primary composite end point of major adverse cardiac events is the occurrence of target vessel revascularization, myocardial infarction and all-cause mortality.
Measured: 1 year
Secondary outcomes (5)
Occurrence of all cause mortality
all cause mortality, confirmed by verifying the vital status of a patient in the Personal Records Database.
Measured: 30 days, 1 year
Occurrence of target vessel revascularization
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.
Measured: 30 days and 1 year
Occurrence of myocardial infarction
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.
Measured: 30 days 1 year
Occurrence of stent thrombosis
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)
Measured: 30 days, 1 year
Occurrence of target lesion revascularization
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.
Measured: 30 days, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Apr 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11,092 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Cathreine BV
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare, Boston Scientific Corporation, Abbott Medical Devices, Salveo Diagnostics
- Responsible party
- Principal investigator, Koen Teeuwen, Cathreine BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114393
- Sponsor's protocol ID
- CathreineBV-OP2
- Acronym
- OPTIMIZE-PCI 2
- Status last verified
- Mar 2026
- First submitted
- 4 Aug 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Koskinas KC, Nakamura M, Raber L, Colleran R, Kadota K, Capodanno D, Wijns W, Akasaka T, Valgimigli M, Guagliumi G, Windecker S, Byrne RA. Current use of intracoronary imaging in interventional practice - Results of a European Association of Percutaneous Cardiovascular Interventions (EAPCI) and Japanese Association of Cardiovascular Interventions and Therapeutics (CVIT) Clinical Practice Survey. EuroIntervention. 2018 Jul 20;14(4):e475-e484. doi: 10.4244/EIJY18M03_01.
PubMed 29537966Bresnahan JF, Kitchell BB, Wildman MF. Facial hair barbering in rats. Lab Anim Sci. 1983 Jun;33(3):290-1.
PubMed 6876735Stone GW, Christiansen EH, Ali ZA, Andreasen LN, Maehara A, Ahmad Y, Landmesser U, Holm NR. Intravascular imaging-guided coronary drug-eluting stent implantation: an updated network meta-analysis. Lancet. 2024 Mar 2;403(10429):824-837. doi: 10.1016/S0140-6736(23)02454-6. Epub 2024 Feb 21.
PubMed 38401549van Beek KAJ, Timmermans MJC, Derks L, Cheng JM, Kraaijeveld AO, Arkenbout EK, Schotborgh CE, Brouwer J, Claessen BE, Lipsic E, Polad J, van Nunen LX, Sjauw K, van Veghel D, Tonino PA, Teeuwen K; 'on behalf of the PCI registration committee of The Netherlands Heart Registration'. Contemporary Use of Post-Dilatation for Stent Optimization During Percutaneous Coronary Intervention; Results From the Netherlands Heart Registration. Catheter Cardiovasc Interv. 2025 Mar;105(4):870-877. doi: 10.1002/ccd.31404. Epub 2025 Jan 8.
PubMed 39777867
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Complex Percutaneous Coronary Intervention With Liberal Use of Intracoronary Imaging Versus Contemporary Practice
- ClinicalTrials.gov ID
- NCT07114393
- Acronym / sponsor ID
- OPTIMIZE-PCI 2 / CathreineBV-OP2
- Conditions
- Coronary Artery Disease, Coronary Artery Disease (Left Main), Chronic Total Occlusion (CTO), Bifurcation Coronary Artery Disease
- Keywords
- percutaneous coronary intervention, intracoronary imaging, stent optimization, complex coronary artery disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 11,092 participants (estimated)
- Lead sponsor
- Cathreine BVUniversity, hospital or other
- Collaborators
- Philips Healthcare, Boston Scientific Corporation, Abbott Medical Devices, Salveo Diagnostics
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Behavioral: Liberal use of intracoronary imaging during complex PCIThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population exists of patients registered in our national PCI registration of the Netherlands Heart Registration after receiving complex PCI. All indications are included (ACS and non-ACS, OHCA, cardiogenic shock).
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (1 listed)
- Non complex PCI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liberal use of intracoronary imaging during complex PCIA 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. | Behavioural | Post-implementation cohort |
Primary outcome
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.
5 secondary outcomes
Occurrence of all cause mortality
Time frame: 30 days, 1 year
Occurrence of target vessel revascularization
Time frame: 30 days and 1 year
Occurrence of myocardial infarction
Time frame: 30 days 1 year
Occurrence of stent thrombosis
Time frame: 30 days, 1 year
Occurrence of target lesion revascularization
Time frame: 30 days, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 29537966Koskinas KC, Nakamura M, Raber L, Colleran R, Kadota K, Capodanno D, Wijns W, Akasaka T, Valgimigli M, Guagliumi G, Windecker S, Byrne RA. Current use of intracoronary imaging in interventional practice - Results of a European Association of Percutaneous Cardiovascular Interventions (EAPCI) and Japanese Association of Cardiovascular Interventions and Therapeutics (CVIT) Clinical Practice Survey. EuroIntervention. 2018 Jul 20;14(4):e475-e484. doi: 10.4244/EIJY18M03_01.
- Background: PubMed 6876735Bresnahan JF, Kitchell BB, Wildman MF. Facial hair barbering in rats. Lab Anim Sci. 1983 Jun;33(3):290-1.
- Background: PubMed 38401549Stone GW, Christiansen EH, Ali ZA, Andreasen LN, Maehara A, Ahmad Y, Landmesser U, Holm NR. Intravascular imaging-guided coronary drug-eluting stent implantation: an updated network meta-analysis. Lancet. 2024 Mar 2;403(10429):824-837. doi: 10.1016/S0140-6736(23)02454-6. Epub 2024 Feb 21.
- Background: PubMed 39777867van Beek KAJ, Timmermans MJC, Derks L, Cheng JM, Kraaijeveld AO, Arkenbout EK, Schotborgh CE, Brouwer J, Claessen BE, Lipsic E, Polad J, van Nunen LX, Sjauw K, van Veghel D, Tonino PA, Teeuwen K; 'on behalf of the PCI registration committee of The Netherlands Heart Registration'. Contemporary Use of Post-Dilatation for Stent Optimization During Percutaneous Coronary Intervention; Results From the Netherlands Heart Registration. Catheter Cardiovasc Interv. 2025 Mar;105(4):870-877. doi: 10.1002/ccd.31404. Epub 2025 Jan 8.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Artery Disease (Left Main), run by Cathreine BV at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Koen Teeuwen, MD PhD (+ 31 040 239 9111, koen.teeuwen@catharinaziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of target vessel revascularization, myocardial infarction and all-cause mortality (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07114393, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.