An interventional study of CT(Computed Tomography) guided Percutaneous Coronary Intervention and IVUS (Intravascular Ultrasound) guided Percutaneous Coronary Intervention in Cardiovascular Diseases, Myocardial Ischemia and Heart Diseases, sponsored by Fundación EPIC. Recruiting at 15 sites in 4 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Fundación EPIC · Not applicable, Interventional, and Treatment
The OPTIMAL randomized clinical trial has been designed to compare two imaging strategies and to test the hypothesis that a calcium modification strategy informed by coronary CT angiography (CCTA) will improve procedural efficiency and effectiveness compared with the current standard of care (IVUS-guided PCI) while achieving similar clinical outcomes in patients with hemodynamically significant calcified coronary artery disease.
The OPTIMAL Trial is a prospective, multicenter, randomized controlled study evaluating whether a coronary CT angiography (CCTA)-guided calcium modification strategy can improve the treatment of patients with hemodynamically significant, calcified coronary artery disease undergoing percutaneous coronary intervention (PCI).
Seven hundred patients with flow-limiting stenosis (FFRCT ≤0.80) and moderate-to-severe calcification on CCTA will be randomized 1:1 to either CCTA-guided or intravascular ultrasound (IVUS)-guided calcium modification. The study includes two co-primary endpoints: (1) superiority in final minimal stent area assessed by IVUS, and (2) non-inferiority in 12-month target vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven revascularization).
CCTA-guided strategy uses advanced calcium characterization to inform pre-procedural planning and selection of plaque modification techniques. IVUS-guided strategy follows contemporary intravascular imaging-based criteria for plaque preparation and PCI optimization.
The trial aims to determine whether leveraging non-invasive CT-based calcium assessment can enhance procedural efficiency and stent results while maintaining clinical safety comparable to IVUS-guided PCI.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 700 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Fundación EPIC is the lead sponsor of 48 studies on the registry; 19 are open to participants now.
Compared within Coronary Artery Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cardiovascular Diseases. 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.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pre-procedural CT will be used to determine lesion characteristics.
Device: CT(Computed Tomography) guided Percutaneous Coronary Intervention
Pre-procedural IVUS will be used to determine lesion characteristics.
Device: IVUS (Intravascular Ultrasound) guided Percutaneous Coronary Intervention
CT will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent
IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent
Demonstrate that CT-guided calcium modification results in a superior final MSA Minimal Stent Area (MSA) - Imaging Endpoint (Superiority)
Final post-PCI minimal stent area per target lesion, measured by independent core laboratory using intravascular ultrasound (IVUS). Assesses whether CT-guided calcium modification results in superior stent expansion compared with IVUS-guided PCI.
Time frame: Perioperative/Periprocedural
Target Vessel Failure (TVF) - Clinical Endpoint (Non-Inferiority)
Composite of cardiac death, target-vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (ID-TVR). TV-MI and ID-TVR are defined according to ARC-2 and the Fourth Universal Definition of MI.
Time frame: 12 months
Procedural efficiency: Procedure time
Time from first angiogram to final angiogram
Time frame: During PCI
Procedural efficiency:Radiation dose-area product
Dose-area product (DAP) recorded during PCI.
Time frame: During PCI
Procedural efficiency: Contrast volume
Total contrast volume (mL) used during PCI.IVUS-Derived Mechanistic Endpoints (Core Lab)
Time frame: During PCI
Procedural Efficiency: Stent Area on Immediate Post-Stent IVUS
MSA prior to any final IVUS-guided optimization.
Time frame: Perioperative/Periprocedural
Procedural Efficiency: Final Stent Area at Original Minimal Lumen Area (MLA)
Stent area at the co-registered site of the baseline MLA.
Time frame: Perioperative/Periprocedural
Procedural Efficiency: Final Stent Area at Site of Maximum Calcium Arc
Stent area measured at the co-registered IVUS site with maximal calcium arc
Time frame: Perioperative/Periprocedural
Procedural Efficiency: Final Stent Area at Site of Maximum Calcium Density
Stent area measured at the co-registered CT-identified region of greatest Hounsfield Unit (HU) calcium density.
Time frame: Perioperative/Periprocedural
Procedural Efficiency: Relative Stent Expansion
Percentage expansion calculated as: MSA ÷ mean distal reference lumen area × 100.
Time frame: Perioperative/Periprocedural
Procedural Efficiency: Number of Calcium Fractures
Fractures identified on intermediary IVUS after calcium modification.
Time frame: Post-modification, pre-stent
Procedural Efficiency: Change in Plaque Attenuation
Change in IVUS plaque characteristics following calcium modification.Angiographic Endpoints
Time frame: Post-modification, pre-stent
Procedural Efficiency: Final Minimal Lumen Diameter
Minimum lumen diameter by quantitative coronary angiography (QCA)
Time frame: Perioperative/Periprocedural
Procedural Efficiency: Final Percent Diameter Stenosis
Percent stenosis of treated lesion after PCI, by QCA
Time frame: Perioperative/Periprocedural
Procedural Efficiency: Final TIMI Flow Grade
Target vessel flow graded 0-3 based on TIMI criteria. Thrombolysis In Myocardial Infarction (TIMI) Flow Grade is a 0-3 angiographic scale used during coronary angiography to describe how well blood is flowing through a coronary artery.TIMI 0 No perfusion, TIMI 1 Penetration without perfusion, TIMI 2 Partial perfusion TIMI 3 Complete perfusion (normal flow)
Time frame: Perioperative/Periprocedural
Procedural Efficiency: Angiographic Complications
According to Coronary dissection (NHLBI classification)
Time frame: Day of procedure
Procedural Efficiency: Angiographic Complications
According to Coronary perforation (Ellis classification)
Time frame: Day of procedure
Procedural Efficiency: Angiographic Complications
Slow-flow / no-reflow
Time frame: Day of procedure
Procedural Efficiency: Angiographic Complications
Side branch closure (TIMI 0-1)
Time frame: Day of procedure
Clinical & Safety Outcomes: Procedural Success
Final stenosis \<30%, TIMI 3 flow, no angiographic complications, and no in-hospital major adverse cardiac events (MACE).
Time frame: Perioperative/Periprocedural
Clinical & Safety Outcomes: Periprocedural Myocardial Infarction (Type 4a MI)
Defined by ARC-2 and 4th Universal Definition of MI (troponin criteria + evidence of ischemia).
Time frame: Day 0-1
Clinical & Safety Outcomes: Stent Thrombosis
Definite or probable stent thrombosis according to ARC-2 definitions.
Time frame: Up to 12 months
Patient-Reported Outcomes: Residual Angina (SAQ-7 Angina Frequency)
Residual angina defined as SAQ-7 Angina Frequency score \<100. Angina frequency represent how often a patient has had angina (chest pain/discomfort) over a recent recall period. Reported as a 0 to 100 scale: 100 = no angina; 0 = angina occurring very frequently
Time frame: 12 months
Patient-Reported Outcomes: Change in Angina (SAQ-7)
Change in angina frequency domain score; positive values indicate improvement. Angina frequency represent how often a patient has had angina (chest pain/discomfort) over a recent recall period. Reported as a 0 to 100 scale: 100 = no angina; 0 = angina occurring very frequently
Time frame: Baseline to 12 months
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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