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NCT Number: NCT06205810

The COMPLETE Study

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OLV Hospital Aalst

Aalst, Oost-Vlaanderen, 9300, Belgium

Location status: Recruiting

Location contact

Eric Wyffels, MD, PhD

PRINCIPAL_INVESTIGATOR

Hilde Delacroix

CONTACT

[email protected]

053724449

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Epicardial stenosis more than 50% by visual assessment.

Exclusion criteria

  • STEMI.
  • Hemodynamic instability.
  • Rapid atrial fibrillation, flutter or arrhythmia (HR > 80 bpm).
  • Insufficient CCTA image quality.
  • Age <18 years.
  • Chronic obstructive pulmonary disease.
  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Assess the accuracy of CCTA to determine minimal stent area with IVUS as reference.

    Time frame: day 0 (day of the procedure)

    To assess the accuracy of CCTA (Coronary Computed Tomography Angiography) to determine minimal stent area with IVUS (Intravascular Ultrasound) as reference.

  2. Determine the diagnostic performance (mean difference) of FFRCT in stented segments with invasive FFR as reference.

    Time frame: day 0 (day of the procedure)

    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.

  3. 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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Sofie Pardaens, MSc, PhD

CONTACT

[email protected]

0032 53 72 42 30

Sponsors and collaborators

Lead sponsor

CoreAalst BV

Industry

Collaborators

  • HeartFlow, Inc.

Registry information

Official study title

Comprehensive Anatomical and Physiological Evaluation of Patients With Stable Coronary Artery Disease.

Acronym: COMPLETE

Important dates

Study start
2023
Primary completion
2030
Study completion
2031
First posted
Jan 16, 2024
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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