An interventional study of Angiographic Guided PCI and OCT Guided PCI in Ischemic Heart Disease, Ischemic Coronary Artery Disease and ACS (Acute Coronary Syndrome), sponsored by Aarhus University Hospital Skejby. Enrolling by invitation at 29 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Aarhus University Hospital Skejby · Not applicable, Interventional, and Treatment
The purpose is to investigate if a strategy of routine OCT based diagnosis and guidance of PCI improves clinical outcomes compared with a standard strategy of guidance by angiography in patients presenting with ACS
Patients presenting with acute coronary syndrome (ACS) have worse short and mid-term prognosis compared with patients revascularized for chronic coronary syndrome. Angiographic assessment of patients with ACS is frequently limited by high ambiguity both in identification of culprit lesions, characterization of non-culprit lesions, and in identification of suboptimal treatment results. Intravascular imaging may improve diagnosis and allow for better treatment optimization during coronary intervention of patients with ACS. The large-scale Chinese IVUS-ACS trial showed a 50% reduction in one-year MACE with IVUS-guided PCI in patients with ACS whereas a number of small studies on routine OCT guiding as well as ACS subgroups in RCTs did not indicate a potential similar benefit with OCT. OCT assessment has several theoretical advantages over IVUS in patients with ACS indicating the need for a well-designed strategy trial on OCT vs angiographic guided PCI.
Hypothesis: Routine OCT-guided diagnosis and revascularization yields superior one-year clinical outcome compared with standard angiography-guided diagnosis and revascularization in patients with acute coronary syndrome Methods: Investigator initiated, open label, prospective, 1:1 randomized, multi-center, clinical outcome, superiority trial.
Primary Endpoint: Major adverse cardiac events (MACE) comprising all-cause death, spontaneous myocardial infarction and stroke.
1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 200 across 865 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Aarhus University Hospital Skejby is the lead sponsor of 60 studies on the registry; 3 are open to participants now.
Compared within Acute Coronary Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Myocardial Ischemia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical inclusion criteria:
Angiographic inclusion criteria:
Exclusion Criteria:
Clinical exclusion criteria
Angiographic exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Revascularization by percutaneous coronary intervention (PCI) guided by angiography alone
Procedure: Angiographic Guided PCI
Revascularization by percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT)
Procedure: OCT Guided PCI
Revascularization by percutaneous coronary intervention (PCI) guided by angiography alone
Revascularization by percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT)
Combined endpoint of major adverse cardiac events (MACE)
Comprising all-cause death, spontaneous myocardial infarction and stroke
Time frame: 12 months
Combined endpoint of major adverse cardiac events (MACE)
Comprising all-cause death, spontaneous myocardial infarction and stroke
Time frame: 30 days, 36 months and 60 months
Patient-oriented composite (PoCE) MACE endpoint
Comprising all cause death, any myocardial infarction, any unplanned revascularization and stroke
Time frame: 30 days, 12 months, 36 months and 60 months
All-cause mortality
All-cause mortality includes death of any cause including cardiac deaths and non-natural causes of deaths
Time frame: 30 days, 12 months, 36 months, 60 months and 10 years
Cardiac death
Encompasses death due to coronary heart disease including fatal myocardial infarction, sudden cardiac death including fatal arrhythmias and cardiac arrest without successful resuscitation, death from heart failure including cardiogenic shock, and death related the cardiac procedure within 28 days from the procedure. If death is not clearly attributable to other non-cardiac causes it is adjudicated as cardiac death.
Time frame: 30 days, 12 months, 36 months and 60 months
Spontaneous myocardial infarction
Following 4th universal MI definition
Time frame: 30 days, 12 months, 36 months and 60 months
Any ischemia-driven revascularization
Any repeat iscemia-driven revascularization (coronary artery bypass grafting or PCI) except staged revascularization planned during the index procedure
Time frame: 30 days, 12 months, 36 months and 60 months
Any unplanned revascularization
Any unplanned repeat revascularization
Time frame: 30 days, 12 months, 36 months and 60 months
Ischemia-driven target lesion revascularization
Any non-staged repeat ischemia-driven revascularization (coronary artery bypass grafting or PCI) of any lesion treated at the index admission
Time frame: 30 days, 12 months, 36 months and 60 months
Ischemia-driven target vessel revascularization
Any non-staged repeat ischemia-driven revascularization (coronary artery bypass grafting or PCI) of any vessel treated at the index admission
Time frame: 30 days, 12 months, 36 months and 60 months
Target lesion revascularization
Any non-staged repeat revascularization (coronary artery bypass grafting or PCI) of any lesion treated at the index admission
Time frame: 30 days, 12 months, 36 months and 60 months
Target vessel revascularization
Any non-staged repeat revascularization (coronary artery bypass grafting or PCI) of any vessel treated at the index admission
Time frame: 30 days, 12 months, 36 months and 60 months
Stroke
Acute neurological deficit of cerebrovascular cause that persists beyond 24 hours with CT or MRI confirmation
Time frame: 30 days, 12 months, 36 months and 60 months
Rose dyspnea Scale
Assesses the severity of dyspnea during specific physical activities, ranging from 0-4. Higher scores indicate worse dyspnea
Time frame: 30 days, 12 months, 36 months and 60 months
CCS-angina class
4-level grading system to categorizes stable angina symptoms based on the severity of physical limitations
Time frame: 30 days, 12 months, 36 months and 60 months
Peri-procedure related MI
According to the ARC-2 and 4th universal definition criterias
Time frame: During or within 48 hours after the procedure (index or staged within the same admission)
Stent thrombosis
Definite, probable or possible in time categories: acute, subacute, late and very late (ARC-2 definitions)
Time frame: 30 days, 12 months, 36 months and 60 months
Contrast induced nephropathy
Defined as a \>50% increase in plasma creatinine after the procedure within the first 48 hours
Time frame: 48h
Contrast volume
Total volume of contrast used at index admission
Time frame: Baseline (index procedure and procedures staged within the same index admission)
Fluoroscopy time
Total fluoroscopy time during index admission
Time frame: Baseline (index procedure and procedures staged within the same index admission)
Length of stents implanted in culprit lesion
Total length of stents implanted in culprit lesion
Time frame: Baseline (index procedure and procedures staged within the same index admission)
Number of NCL treated
Number of Non Culprit Lesions treated
Time frame: Baseline (index procedure and procedures staged within the same index admission)
Procedural failure
No stent implanted in target lesion
Time frame: Baseline (index procedure and procedures staged within the same index admission)
Procedural success
TIMI III flow and less than 30% diameter stenosis in target segments by corelab QCA
Time frame: Baseline (index procedure and procedures staged within the same index admission)
Procedure time
Total procedure time at index admission
Time frame: Baseline (index procedure and procedures staged within the same index admission)
Plan to share: Yes — Limited and pseudo-anonymized data will be transferred to studies investigating the effect of OCT treatment across other studies, so-called meta-analyses. These meta-analyses will be carried out with Rigshospitalet (Copenhagen, Denmark) and the Cardiovascular Research Foundation (New York, USA). Full anonymization means that the information cannot be linked to individuals. The studies to which data are transferred comply with the General Data Protection Regulation and the Danish Data Protection Act. Data from this study will also be transferred to a project at Aarhus University investigating prognosis across patient groups treated with OCT.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Aarhus University Hospital Skejby