Coronary Artery DiseaseCOMPLETENCT06205810
The COMPLETE Study
An observational study of Coronary Artery Disease, run by CoreAalst BV at 1 site in Belgium.
Trial summary
The COMPLETE study is a single-centre, investigator-initiated study of patients with an indication for invasive coronary angiography with CCTA performed during the diagnostic evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Oct 2023to 15 Oct 2031
- How long will I take part?
- 3 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Coronary Artery Disease with an epicardial stenosis of more than 50% of visual assessment.
Who may be able to join
- 1. Epicardial stenosis more than 50% by visual assessment.
Who cannot join
- STEMI.
- Hemodynamic instability.
- Rapid atrial fibrillation, flutter or arrhythmia (HR > 80 bpm).
- Insufficient CCTA image quality.
- Age <18 years.
- Chronic obstructive pulmonary disease.
Show all 20Show fewer
- Contraindication to adenosine.
- NYHA class III or IV, or last known left ventricular ejection fraction <30%.
- Uncontrolled or recurrent ventricular tachycardia.
- History of recent stroke (≤90 days).
- Prior myocardial infarction.
- History of ischemic stroke (>90 days) with modified RANKIN score ≥ 2.
- History of any hemorrhagic stroke.
- Previous coronary artery bypass surgery.
- Active liver disease or hepatic dysfunction, defined as AST or ALT > 3 times the ULN.
- Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m2.
- BMI >35 kg/m2.
- Nitrate intolerance
- Contra-indication to heart rate lowering drugs.
- Unable to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
OLV Hospital Aalst
Aalst, Oost-Vlaanderen, 9300
Hilde Delacroix, 053724449, hilde.delacroix@olvz-aalst.be
Eric Wyffels, MD, PhD
About this study
Official title: Comprehensive Anatomical and Physiological Evaluation of Patients With Stable Coronary Artery Disease.
The COMPLETE study is a single-centre, investigator-initiated study of patients with an indication for invasive coronary angiography with CCTA performed during the diagnostic evaluation. After identifying the presence of a coronary stenosis, defined as an epicardial lesion >50% stenosis on CCTA, patients eligible for the study will be invited to participate.
The main aim of this trial is to assess the accuracy of coronary CT angiography to quantify total atheroma volume with intravascular ultrasound as reference.
Read more
Patients will be divided into 2 sub-groups:
Cohort 1: Patients with stable coronary artery disease or stabilized acute coronary syndromes with a clinical indication for invasive coronary angiography.
Cohort 2: Patients previously revascularized with a metallic stent with a clinical indication for invasive coronary angiography.
In both cohorts, patients should have undergone coronary CT angiography as part of the standard of care.
Patients included in the study will be managed according to the standard of care for the assessment of coronary artery disease. Clinical follow-up will be collected until 3 years follow-up.
- Conditions
- Coronary Artery Disease
- Keywords
- FFRCT
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the accuracy of CCTA to quantify total atheroma volume (TAV) with IVUS as reference.
To assess the accuracy of CCTA (Coronary Computed Tomography Angiography) to quantify total atheroma volume (TAV) with IVUS (Intravascular Ultrasound) as reference.
Measured: day 0 (day of the procedure)
Secondary outcomes (3)
Assess the accuracy of CCTA to determine minimal stent area with IVUS as reference.
To assess the accuracy of CCTA (Coronary Computed Tomography Angiography) to determine minimal stent area with IVUS (Intravascular Ultrasound) as reference.
Measured: day 0 (day of the procedure)
Determine the diagnostic performance (mean difference) of FFRCT in stented segments with invasive FFR as reference.
To determine the diagnostic performance (mean difference) of FFRCT (Fractional Flow Reserve derived from CT) in stented segments with invasive FFR (Fractional Flow Reserve ) as reference.
Measured: day 0 (day of the procedure)
Describe the impact of coronary microvascular dysfunction assessed by IMR and absolute coronary resistance on the accuracy of FFRCT.
To describe the impact of coronary microvascular dysfunction assessed by IMR (Index of Microcirculatory Resistance) and absolute coronary resistance on the accuracy of FFRCT (Fractional Flow Reserve derived from CT).
Measured: day 0 (day of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start24 Oct 2023
- Primary completion15 Oct 2030 (estimated)
- Study completion15 Oct 2031 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- CoreAalst BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- HeartFlow, Inc.
- Responsible party
- Sponsor
- Investigators
- Eric Wyffels, MD, PhD, Principal investigator, OLV Hospital Aalst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205810
- Sponsor's protocol ID
- CA-063
- Acronym
- COMPLETE
- Status last verified
- Jan 2026
- First submitted
- 28 Nov 2023
- Last updated
- 20 Jan 2026
- 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 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Anatomical and Physiological Evaluation of Patients With Stable Coronary Artery Disease.
- ClinicalTrials.gov ID
- NCT06205810
- Acronym / sponsor ID
- COMPLETE / CA-063
- Conditions
- Coronary Artery Disease
- Keywords
- FFRCT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- CoreAalst BVIndustry (pharma, biotech, devices)
- Collaborators
- HeartFlow, Inc.
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 15 Oct 2030 (estimated)
- Study completion
- 15 Oct 2031 (estimated)
- First posted
- 16 Jan 2024 (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.
The COMPLETE study is a single-centre, investigator-initiated study of patients with an indication for invasive coronary angiography with CCTA performed during the diagnostic evaluation. After identifying the presence of a coronary stenosis, defined as an epicardial lesion >50% stenosis on CCTA, patients eligible for the study will be invited to participate.
The main aim of this trial is to assess the accuracy of coronary CT angiography to quantify total atheroma volume with intravascular ultrasound as reference.
Patients will be divided into 2 sub-groups:
Cohort 1: Patients with stable coronary artery disease or stabilized acute coronary syndromes with a clinical indication for invasive coronary angiography.
Cohort 2: Patients previously revascularized with a metallic stent with a clinical indication for invasive coronary angiography.
In both cohorts, patients should have undergone coronary CT angiography as part of the standard of care.
Patients included in the study will be managed according to the standard of care for the assessment of coronary artery disease. Clinical follow-up will be collected until 3 years follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Coronary Artery Disease with an epicardial stenosis of more than 50% of visual assessment.
Key inclusion criteria (1 listed)
- 1. Epicardial stenosis more than 50% by visual assessment.
Key exclusion criteria (20 listed)
- STEMI.
- Hemodynamic instability.
- Rapid atrial fibrillation, flutter or arrhythmia (HR > 80 bpm).
- Insufficient CCTA image quality.
- Age <18 years.
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
assess the accuracy of CCTA to quantify total atheroma volume (TAV) with IVUS as reference.
Time frame: day 0 (day of the procedure)
To assess the accuracy of CCTA (Coronary Computed Tomography Angiography) to quantify total atheroma volume (TAV) with IVUS (Intravascular Ultrasound) as reference.
3 secondary outcomes
Assess the accuracy of CCTA to determine minimal stent area with IVUS as reference.
Time frame: day 0 (day of the procedure)
Determine the diagnostic performance (mean difference) of FFRCT in stented segments with invasive FFR as reference.
Time frame: day 0 (day of the procedure)
Describe the impact of coronary microvascular dysfunction assessed by IMR and absolute coronary resistance on the accuracy of FFRCT.
Time frame: day 0 (day of the procedure
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 20 Jan 2026.
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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.
Eric Wyffels, MD, PhD principal investigator
OLV Hospital Aalst
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, run by CoreAalst BV at 1 site in Belgium.
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 1 inclusion and 20 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 20 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 1 site in Belgium. 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 Sofie Pardaens, MSc, PhD (0032 53 72 42 30, sofiepardaens@coreaalst.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess the accuracy of CCTA to quantify total atheroma volume (TAV) with IVUS as reference. (time frame: day 0 (day of the procedure)). 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 20 Jan 2026.