Coronary Artery DiseaseP4NCT05253677
Precise Procedural and PCI Plan (P4)
A study testing CT-guided PCI and IVUS-guided PCI in people with Coronary Artery Disease, run by CoreAalst BV at 23 sites in 8 countries.
Trial summary
Computed tomography (CT) has become an established tool in the diagnostic workup of patients with suspected coronary artery disease (CAD). The availability of coronary CT angiography (CCTA) before the invasive procedure allows stratifying case complexity and can be used to improve patient selection for PCI, to plan… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CT-guided PCI and IVUS-guided PCI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,090 participants
- Where
- 23 sitesin 8 countries
- Study dates
- 1 Apr 2022to Oct 2026
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject must be at least 18 years of age and younger than 80 years old.
- Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for elective PCI.
- Patients with a clinical indication for revascularization presenting with stable coronary artery disease or stabilized acute coronary syndrome defined as follows unstable angina (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC), patients with NSTEMI without high-risk features such as recurrence of chest pain, ST-segment depression>1mm in ≥6 leads plus ST-segment elevation in aVR, life-threatening arrhythmias, mechanical complications of MI, resuscitated cardiac arrest, GRACE risk score>140.
- All target lesions must be planned for treatment only in vessels with RVD ≥2.5 mm and ≤4.0 mm.
- No more than 2 target vessels are allowed. A bifurcation counts as a single lesion even if the side branch is planned to be treated.
- Subject must provide written Informed Consent before any study-related procedure.
Who cannot join
- Age <18 years or ≥80 years old
- STEMI as clinical presentation.
- Uncontrolled or recurrent ventricular tachycardia.
- Hemodynamic instability.
- Severe renal dysfunction, defined as an eGFR ≤30 mL/min/1.73 m2.
- Atrial fibrillation, flutter, or arrhythmias.
Show all 25Show fewer
- Previous PCI or CABG.
- The target lesion is in the left main coronary artery
- BMI ≥35 kg/m2.
- Insufficient CT quality assessed by the Core lab.
- Comorbidity with life expectancy ≤ 2 years.
- Inability to take DAPT (both aspirin and a P2Y12 inhibitor) for at least 12 months in the patient presenting with an ACS, or at least 6 months in the patient presenting with stable CAD, unless the patient is also taking chronic oral anticoagulation in which case a shorter duration of DAPT may be prescribed per local standard of care.
- Planned major cardiac or non-cardiac surgery within 24 months after the index procedure Note: Major surgery is any invasive operative procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered. Note: Minor surgery is an operation on the superficial structures of the body or a manipulative procedure that does not involve a serious risk. Planned minor surgery is not excluded.
- Prior PCI within the target vessel within 12 months.
- Subject has known hypersensitivity or contraindication to any of the study drugs (including all P2Y12 inhibitors, one or more components of the study devices, including everolimus, zotarolimus, biolimus, sirolimus, cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoropolymers, or radiocontrast dye that cannot be adequately pre-medicated.
- The subject has received a solid organ transplant that is functioning or is active on a waiting list for any solid organ transplants with expected transplantation within 24 months.
- The subject receives immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
- The subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy) or the chest/mediastinum.
- Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
- The subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
- The subject has a history of bleeding diathesis or coagulopathy or has had a significant gastro-intestinal or significant urinary bleed within the past six months. The subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc. The subject has a life expectancy <2 years for any non-cardiac cause.
- Subject is currently participating in another investigational drug or device clinical study.
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- Unable to provide written informed consent (IC).
Trial locations and contacts
23 sites in 8 countries.
23 sites in 8 countries
United Kingdom7 sites
Golden Jubilee National Hospital
Clydebank, G81 4DY,
Liverpool Heart and Chest Hospital
Liverpool, L14 3PE
St George's University Hospitals NHS Foundation Trust
London, ,SW17 0QT
Barts Health NHS Trust
London, E1 1FR
Guy's and St Thomas' NHS Foundation Trust
London
Freeman Hospital
Newcastle, NE7 7DN
University Hospitals Dorset NHS Foundation Trust, Poole Hospital
Poole, Dorset, BH15 2JB
Italy4 sites
Azienda Ospedaliero Universitaria di Ferrara
Cona, 44124
Humanitas University
Milan, 20090
Ospedale Galeazzi Sant'Ambrogio
Milan, 20149
Centro Cardiologico Monzino S.P.A.
Milan
United States3 sites
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
St. Francis Hospital & Heart Center
Roslyn, New York, 11576
Belgium3 sites
OLV Hospital
Aalst, 9300
Hartcentrum ZNA Antwerp
Antwerp, 2000
UZ Brussels
Jette, Brussels Capital, 1090
Denmark3 sites
Aarhus Universitetshospital
Aarhus, 8200
Rigshospitalet
Copenhagen, 2100
Gentofte hospital
Gentofte Municipality, Hellerup, 2900
About this study
Official title: Precise Procedural and PCI Plan (P4) Randomized Clinical Trial Integration of Coronary Computed Tomography Angiography in the Catheterization Laboratory to Plan and Guide Coronary Percutaneous Procedures
Computed tomography (CT) has become an established tool in the diagnostic workup of patients with suspected coronary artery disease (CAD). The availability of coronary CT angiography (CCTA) before the invasive procedure allows stratifying case complexity and can be used to improve patient selection for PCI, to plan and guide therapeutic interventions. Beyond the diagnostic and therapeutic phase, it helps to better organize the catheterization laboratory workflow.
The P4 study is an investigator-initiated, multicenter, randomized study with a non-inferiority design of patients with an indication for PCI aiming at comparing clinical outcomes between two imaging strategies to guide PCI, being coronary CT-guided PCI strategy (investigational technology) and IVUS-guided PCI strategy (comparator).
After identifying the presence of a significant coronary stenosis, the patient will be randomized either to CT- or IVUS-guided PCI groups. Both CT and IVUS-guided PCI will be performed following the P4 trial protocol. When the procedure is completed, post-PCI FFR will be measured. All patients will be followed in hospital, at 30 days (±15 days), 12 months (±1 month) and yearly until 5 year.
- Conditions
- Coronary Artery Disease
- Being tested
- CT-guided PCI, IVUS-guided PCI
- 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.
CT-guided PCIDevice
CT-guided PCI with standardized pre-procedural planning and online guidance.
IVUS-guided PCIDevice
use of IVUS during PCI procedure (standard of care)
| Study group | Role | What they receive |
|---|---|---|
| CT-guided PCI strategy | Experimental | QAngio CT Research Edition is a software suite providing several functionalities for the analysis of coronary computed tomography angiography (CCTA) scans to extract and present relevant information on the coronary vasculature for further clinical investigation.
Also, QAngio CT Research Edition allows to export this information for later viewing during x-ray angiography (XA) procedures to help physicians plan and guide the interventional procedure. Receives: Device: CT-guided PCI |
| intravascular ultrasound (IVUS)-guided PCI strategy | Active comparator | Intravascular ultrasound (IVUS) is an invasive intravascular imaging technique able to visualize the coronary vessel. The use of IVUS-guided PCI has been endorsed an recommended by the European Society of Cardiology. The device is considered part of standard of clinical care. Receives: Device: IVUS-guided PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of MACE between CCTA- and IVUS-guided PCI strategy
Comparison of the rate of the composite of major adverse cardiovascular events, defined as cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization between CT- and IVUS-guided PCI strategies at 12-month follow-up
Measured: 12 months follow-up
Secondary outcomes (23)
Compare in-hospital resource utilization between CCTA- and IVUS-guided PCI strategies.
Compare in-hospital resource utilization (cost from all the procedures during the hospitalisation to discharge in Euros) between CCTA- and IVUS-guided PCI strategies.
Measured: during the intervention
Compare resource utilization at 12-month follow-up between CCTA- and IVUS-guided PCI strategies
Compare resource utilization (procedural cost and cost from additional interventions in Euros) at 12-month follow-up between CCTA- and IVUS-guided PCI
Measured: 12 months follow-up
Compare radiation dose (defined as radiation dose from the invasive procedure) between CCTA- and IVUS- guided PCI strategies.
Measured: periprocedural time frame
Compare contrast volume (defined as contrast volume used during the invasive procedure) between CCTA- and IVUS- guided PCI strategies.
Measured: periprocedural time frame
Compare the rate of cardiac death between CCTA- and IVUS-guided PCI strategies.
Measured: 12 months follow-up
Compare the rate of target-vessel myocardial infarction between CCTA- and IVUS-guided PCI strategies.
Measured: 12 months follow-up
Compare the rate of ischemia-driven target-vessel revascularization between CCTA- and IVUS-guided PCI strategies.
Measured: 12 months follow-up
Compare the rate of PCI-related MI (type 4a a, 4th Universal Definition of MI) between CCTA- and IVUS-guided PCI strategies
Measured: during the procedure
Compare the degree of functional revascularization, defined by post-PCI FFR values measured immediately after PCI between CCTA- and IVUS-guided PCI strategies.
Measured: periprocedural time frame
Compare the degree of functional revascularization, defined by FFRCT Planner, between CCTA- and IVUS-guided PCI strategies.
Measured: periprocedural time frame
Compare the rate of MACE between patient with complete and incomplete functional revascularization based on the FFRCT Planner, at 12-month follow-up.
Measured: 12 months follow-up
Compare the rate of MACE between patient with complete and incomplete functional revascularization based on the post-PCI FFR values measured immediately after PCI, at 12-month follow-up.
Measured: 12 months follow-up
Assess the agreement on post-PCI FFR between the FFRCT Planner and the invasive measurement.
Measured: periprocedural time frame
Assess the agreement between the FFRCT Planner strategy and the actual treatment performed.
Measured: periprocedural time frame
Assess the CCTA predictors of stent under expansion.
To assess which characteristics of the plaque, defined by CT, can predict whether the stent is under expansion (by multivariate analysis on the data)
Measured: periprocedural time frame
To compare angiographic Endpoints (Core Lab assessed QCA): - Final (post-PCI) minimal lumen diameter. - Final (post-PCI) percent diameter stenosis. - Acute lumen gain post-intervention.
Measured: periprocedural time frame
To compare the maximum device size (stent or post-dilatation balloon)/reference vessel diameter ratio) CCTA- and IVUS-guided PCI strategies.
Measured: periprocedural time frame
To compare angiographic complications CCTA- and IVUS guided PCI strategies.
Angiographic dissection ≥ NHLBI type B, perforations (Ellis's classification), intra-procedural thrombotic events (including slow-flow, no-reflow, side branch closure, distal embolization, and intra-procedural stent thrombosis, as per the standard angiographic core laboratory definitions
Measured: periprocedural time frame
To compare procedural time (defined as the time from first to the last angiography) between CCTA- and IVUS-guided PCI strategies.
Measured: periprocedural time frame
Compare the rate of symptoms-free status assessed by the SAQ-7 between CCTA- and IVUS-guided PCI strategies at 12-months.
Measured: 12 months follow-up
Compare the change in symptoms assessed by the change of Seattle Angina Questionnaire (SAQ-7) scores between CCTA- and IVUS-guided PCI strategies at 12-months.
Measured: 12 months follow-up
Compare the change in symptoms assessed by the change of EuroQol 5 dimensions - 5 levels (EQ-5D-5L) scores between CCTA- and IVUS-guided PCI strategies at 12-months.
Measured: 12 months follow-up
Assess the capacity of the FFRCT Planner (predicted post-PCI FFR) to predict adverse events.
Assess whether the predicted post-PCI FFR value which is calculated by the FFRCT-planner can predict adverse outcomes
Measured: 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Apr 2022
- Primary completion4 Aug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,090 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CoreAalst BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Collet Bortone, MD, PhD, Principal investigator, CoreAalst BVDaniele Andreini, MD, PhD, Principal investigator, Milan University, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253677
- Sponsor's protocol ID
- CRI-052
- Acronym
- P4
- Status last verified
- Jan 2026
- First submitted
- 6 Dec 2021
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precise Procedural and PCI Plan (P4) Randomized Clinical Trial Integration of Coronary Computed Tomography Angiography in the Catheterization Laboratory to Plan and Guide Coronary Percutaneous Procedures
- ClinicalTrials.gov ID
- NCT05253677
- Acronym / sponsor ID
- P4 / CRI-052
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,090 participants (estimated)
- Lead sponsor
- CoreAalst BVIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 4 Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 24 Feb 2022 (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.
Computed tomography (CT) has become an established tool in the diagnostic workup of patients with suspected coronary artery disease (CAD). The availability of coronary CT angiography (CCTA) before the invasive procedure allows stratifying case complexity and can be used to improve patient selection for PCI, to plan and guide therapeutic interventions. Beyond the diagnostic and therapeutic phase, it helps to better organize the catheterization laboratory workflow.
The P4 study is an investigator-initiated, multicenter, randomized study with a non-inferiority design of patients with an indication for PCI aiming at comparing clinical outcomes between two imaging strategies to guide PCI, being coronary CT-guided PCI strategy (investigational technology) and IVUS-guided PCI strategy (comparator).
After identifying the presence of a significant coronary stenosis, the patient will be randomized either to CT- or IVUS-guided PCI groups. Both CT and IVUS-guided PCI will be performed following the P4 trial protocol. When the procedure is completed, post-PCI FFR will be measured. All patients will be followed in hospital, at 30 days (±15 days), 12 months (±1 month) and yearly until 5 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-guided PCI strategy | Experimental | Device: CT-guided PCIQAngio CT Research Edition is a software suite providing several functionalities for the analysis of coronary computed tomography angiography (CCTA) scans to extract and present relevant information on the coronary vasculature for further clinical investigation. Also, QAngio CT Research Edition allows to export this information for later viewing during x-ray angiography (XA) procedures to help physicians plan and guide the interventional procedure. |
| intravascular ultrasound (IVUS)-guided PCI strategy | Active comparator | Device: IVUS-guided PCIIntravascular ultrasound (IVUS) is an invasive intravascular imaging technique able to visualize the coronary vessel. The use of IVUS-guided PCI has been endorsed an recommended by the European Society of Cardiology. The device is considered part of standard of clinical care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject must be at least 18 years of age and younger than 80 years old.
- Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for elective PCI.
- Patients with a clinical indication for revascularization presenting with stable coronary artery disease or stabilized acute coronary syndrome defined as follows unstable angina (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC), patients with NSTEMI without high-risk features such as recurrence of chest pain, ST-segment depression>1mm in ≥6 leads plus ST-segment elevation in aVR, life-threatening arrhythmias, mechanical complications of MI, resuscitated cardiac arrest, GRACE risk score>140.
- All target lesions must be planned for treatment only in vessels with RVD ≥2.5 mm and ≤4.0 mm.
- No more than 2 target vessels are allowed. A bifurcation counts as a single lesion even if the side branch is planned to be treated.
Key exclusion criteria (25 listed)
- Age <18 years or ≥80 years old
- STEMI as clinical presentation.
- Uncontrolled or recurrent ventricular tachycardia.
- Hemodynamic instability.
- Severe renal dysfunction, defined as an eGFR ≤30 mL/min/1.73 m2.
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 |
|---|---|---|
| CT-guided PCICT-guided PCI with standardized pre-procedural planning and online guidance. | Device | CT-guided PCI strategy |
| IVUS-guided PCIuse of IVUS during PCI procedure (standard of care) | Device | intravascular ultrasound (IVUS)-guided PCI strategy |
Primary outcome
rate of MACE between CCTA- and IVUS-guided PCI strategy
Time frame: 12 months follow-up
Comparison of the rate of the composite of major adverse cardiovascular events, defined as cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization between CT- and IVUS-guided PCI strategies at 12-month follow-up
23 secondary outcomes
Compare in-hospital resource utilization between CCTA- and IVUS-guided PCI strategies.
Time frame: during the intervention
Compare resource utilization at 12-month follow-up between CCTA- and IVUS-guided PCI strategies
Time frame: 12 months follow-up
Compare radiation dose (defined as radiation dose from the invasive procedure) between CCTA- and IVUS- guided PCI strategies.
Time frame: periprocedural time frame
Compare contrast volume (defined as contrast volume used during the invasive procedure) between CCTA- and IVUS- guided PCI strategies.
Time frame: periprocedural time frame
Compare the rate of cardiac death between CCTA- and IVUS-guided PCI strategies.
Time frame: 12 months follow-up
Compare the rate of target-vessel myocardial infarction between CCTA- and IVUS-guided PCI strategies.
Time frame: 12 months follow-up
Compare the rate of ischemia-driven target-vessel revascularization between CCTA- and IVUS-guided PCI strategies.
Time frame: 12 months follow-up
Compare the rate of PCI-related MI (type 4a a, 4th Universal Definition of MI) between CCTA- and IVUS-guided PCI strategies
Time frame: during the procedure
Compare the degree of functional revascularization, defined by post-PCI FFR values measured immediately after PCI between CCTA- and IVUS-guided PCI strategies.
Time frame: periprocedural time frame
Compare the degree of functional revascularization, defined by FFRCT Planner, between CCTA- and IVUS-guided PCI strategies.
Time frame: periprocedural time frame
Compare the rate of MACE between patient with complete and incomplete functional revascularization based on the FFRCT Planner, at 12-month follow-up.
Time frame: 12 months follow-up
Compare the rate of MACE between patient with complete and incomplete functional revascularization based on the post-PCI FFR values measured immediately after PCI, at 12-month follow-up.
Time frame: 12 months follow-up
Assess the agreement on post-PCI FFR between the FFRCT Planner and the invasive measurement.
Time frame: periprocedural time frame
Assess the agreement between the FFRCT Planner strategy and the actual treatment performed.
Time frame: periprocedural time frame
Assess the CCTA predictors of stent under expansion.
Time frame: periprocedural time frame
To compare angiographic Endpoints (Core Lab assessed QCA): - Final (post-PCI) minimal lumen diameter. - Final (post-PCI) percent diameter stenosis. - Acute lumen gain post-intervention.
Time frame: periprocedural time frame
To compare the maximum device size (stent or post-dilatation balloon)/reference vessel diameter ratio) CCTA- and IVUS-guided PCI strategies.
Time frame: periprocedural time frame
To compare angiographic complications CCTA- and IVUS guided PCI strategies.
Time frame: periprocedural time frame
To compare procedural time (defined as the time from first to the last angiography) between CCTA- and IVUS-guided PCI strategies.
Time frame: periprocedural time frame
Compare the rate of symptoms-free status assessed by the SAQ-7 between CCTA- and IVUS-guided PCI strategies at 12-months.
Time frame: 12 months follow-up
Compare the change in symptoms assessed by the change of Seattle Angina Questionnaire (SAQ-7) scores between CCTA- and IVUS-guided PCI strategies at 12-months.
Time frame: 12 months follow-up
Compare the change in symptoms assessed by the change of EuroQol 5 dimensions - 5 levels (EQ-5D-5L) scores between CCTA- and IVUS-guided PCI strategies at 12-months.
Time frame: 12 months follow-up
Assess the capacity of the FFRCT Planner (predicted post-PCI FFR) to predict adverse events.
Time frame: 12 months follow-up
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 21 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Carlos Collet Bortone, MD, PhD principal investigator
CoreAalst BV
Daniele Andreini, MD, PhD principal investigator
Milan University, Milan, Italy
23 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-guided PCI and IVUS-guided PCI in people with Coronary Artery Disease, run by CoreAalst BV at 23 sites in 8 countries.
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 6 inclusion and 25 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: under way, not looking for participants, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United Kingdom, Italy, United States, Belgium, Denmark and 3 more countries. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of MACE between CCTA- and IVUS-guided PCI strategy (time frame: 12 months follow-up). 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 21 Jan 2026.