Coronary Arterial DiseaseORANGENCT07293858
Optical Coherence Tomography: Prognostic Value and Artificial Intelligence
An observational study of Coronary Arterial Disease, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
This study aims to evaluate the prognostic value of optical coherence tomography (OCT) imaging of the coronary arteries. OCT provides high-resolution images of the vessel wall and stented segments during routine cardiac catheterization. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Arterial Disease
- How many people
- 1,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Nov 2021to 31 Dec 2028
- How long will I take part?
- 10 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of all patients who have undergone intracoronary OCT imaging of the coronary arteries as part of their routine cardiac catheterization. This is an all-comer population with no restrictions regarding indication, diagnosis, age, or comorbidities. The decision to perform OCT is made independently by the treating cardiologist. After the procedure, patients are invited to participate in this prospective registry and are included only after providing written informed consent.
Who may be able to join
- All consecutive patients undergoing intracoronary OCT imaging at the Radboud University Medical Center, and any additional centers that may join the study in the future.
- OCT performed at the discretion of the treating physician, according to contemporary clinical guidelines.
- Written informed consent obtained after the procedure.
Who cannot join
- Patients who decline or are unable to provide informed consent. (Only patients who provide consent can be included.
- Patients for whom follow-up or data collection is not feasible (e.g., no valid contact details).
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
Radboudumc
Nijmegen, Gelderland, 6525GA
Niels van Royen, Prof. dr., +31243614533, niels.vanroyen@radboudumc.nl
About this study
This study aims to evaluate the prognostic value of optical coherence tomography (OCT) imaging of the coronary arteries. OCT provides high-resolution images of the vessel wall and stented segments during routine cardiac catheterization. All patients who undergo OCT as part of their clinical care are invited to participate in this prospective registry.
The study will examine whether specific OCT-derived characteristics-such as plaque morphology, vulnerable features, or indicators of stent optimization-are associated with long-term clinical outcomes. Follow-up information on symptoms, medication use, hospitalizations, cardiac procedures, and major cardiac events will be collected through medical records, questionnaires, and national registry data over a period of up to 10 years.
Read more
In addition, pseudonymized OCT pullbacks will be used to support the development of an artificial intelligence (AI) algorithm for automated annotation of OCT images. This algorithm may help improve the clinical interpretation of OCT by identifying relevant imaging features in a consistent and efficient manner.
Participation is voluntary and includes permission to use clinical data, OCT images, and follow-up information for research purposes. Data are coded to protect participant privacy and stored securely according to applicable regulations. The results of this study may contribute to better understanding of coronary plaque characteristics and may support improved decision-making in interventional cardiology.
- Conditions
- Coronary Arterial Disease
- Keywords
- Optical Coherence Tomography, Artificial Intelligence
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between OCT-derived plaque and stent characteristics and long-term clinical outcomes
Assessment of whether specific OCT-derived characteristics-such as plaque morphology, vulnerable features, stent deployment quality, and other intraluminal or vessel wall findings-are associated with long-term clinical outcomes. Outcomes include cardiac symptoms, cardiac events, coronary interventions, hospitalization, and death, based on medical records, questionnaire data, and national registries.
Measured: 10 years
Secondary outcomes (1)
Performance of an automated OCT annotation algorithm
Evaluation of the accuracy and feasibility of an AI-based algorithm for automated annotation of OCT pullbacks. Pseudonymized OCT images will be used to train and validate automated detection of plaque features, stent characteristics, and other relevant imaging markers. Comparison will be made with expert manual annotation.
Measured: Baseline (OCT acquisition) to algorithm development period (≤5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start26 Nov 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial 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
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293858
- Sponsor's protocol ID
- 2021-13271
- Acronym
- ORANGE
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography: Prognostic Value and Artificial Intelligence
- ClinicalTrials.gov ID
- NCT07293858
- Acronym / sponsor ID
- ORANGE / 2021-13271
- Conditions
- Coronary Arterial Disease
- Keywords
- Optical Coherence Tomography, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Dec 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.
This study aims to evaluate the prognostic value of optical coherence tomography (OCT) imaging of the coronary arteries. OCT provides high-resolution images of the vessel wall and stented segments during routine cardiac catheterization. All patients who undergo OCT as part of their clinical care are invited to participate in this prospective registry.
The study will examine whether specific OCT-derived characteristics-such as plaque morphology, vulnerable features, or indicators of stent optimization-are associated with long-term clinical outcomes. Follow-up information on symptoms, medication use, hospitalizations, cardiac procedures, and major cardiac events will be collected through medical records, questionnaires, and national registry data over a period of up to 10 years.
In addition, pseudonymized OCT pullbacks will be used to support the development of an artificial intelligence (AI) algorithm for automated annotation of OCT images. This algorithm may help improve the clinical interpretation of OCT by identifying relevant imaging features in a consistent and efficient manner.
Participation is voluntary and includes permission to use clinical data, OCT images, and follow-up information for research purposes. Data are coded to protect participant privacy and stored securely according to applicable regulations. The results of this study may contribute to better understanding of coronary plaque characteristics and may support improved decision-making in interventional cardiology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of all patients who have undergone intracoronary OCT imaging of the coronary arteries as part of their routine cardiac catheterization. This is an all-comer population with no restrictions regarding indication, diagnosis, age, or comorbidities. The decision to perform OCT is made independently by the treating cardiologist. After the procedure, patients are invited to participate in this prospective registry and are included only after providing written informed consent.
Key inclusion criteria (3 listed)
- All consecutive patients undergoing intracoronary OCT imaging at the Radboud University Medical Center, and any additional centers that may join the study in the future.
- OCT performed at the discretion of the treating physician, according to contemporary clinical guidelines.
- Written informed consent obtained after the procedure.
Key exclusion criteria (2 listed)
- Patients who decline or are unable to provide informed consent. (Only patients who provide consent can be included.
- Patients for whom follow-up or data collection is not feasible (e.g., no valid contact details).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relationship between OCT-derived plaque and stent characteristics and long-term clinical outcomes
Time frame: 10 years
Assessment of whether specific OCT-derived characteristics-such as plaque morphology, vulnerable features, stent deployment quality, and other intraluminal or vessel wall findings-are associated with long-term clinical outcomes. Outcomes include cardiac symptoms, cardiac events, coronary interventions, hospitalization, and death, based on medical records, questionnaire data, and national registries.
1 secondary outcome
Performance of an automated OCT annotation algorithm
Time frame: Baseline (OCT acquisition) to algorithm development period (≤5 years)
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 19 Dec 2025.
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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 Arterial Disease, run by Radboud University Medical Center 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 3 inclusion and 2 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 19 Dec 2025. 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 Joske L. van der Zande (0622997212 ext. +31611469960, joske.vanderzande@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between OCT-derived plaque and stent characteristics and long-term clinical outcomes (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2025.