The COMPLETE Study (COMPLETE)

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.

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 Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Sofie Pardaens, MSc, PhD; Phone Number: 0032 53 72 42 30; Email: sofiepardaens@coreaalst.com

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Aalst, Oost-Vlaanderen, Belgium, 9300
      • Recruiting
      • OLV Hospital Aalst
      • Contact: Hilde Delacroix; Phone Number: 053724449; Email: hilde.delacroix@olvz-aalst.be
      • Principal Investigator: Eric Wyffels, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with Coronary Artery Disease with an epicardial stenosis of more than 50% of visual assessment.

Description

Inclusion Criteria:

1. Epicardial stenosis more than 50% by visual assessment.

Exclusion Criteria:

1. STEMI.
2. Hemodynamic instability.
3. Rapid atrial fibrillation, flutter or arrhythmia (HR > 80 bpm).
4. Insufficient CCTA image quality.
5. Age <18 years.
6. Chronic obstructive pulmonary disease.
7. Contraindication to adenosine.
8. NYHA class III or IV, or last known left ventricular ejection fraction <30%.
9. Uncontrolled or recurrent ventricular tachycardia.
10. History of recent stroke (≤90 days).
11. Prior myocardial infarction.
12. History of ischemic stroke (>90 days) with modified RANKIN score ≥ 2.
13. History of any hemorrhagic stroke.
14. Previous coronary artery bypass surgery.
15. Active liver disease or hepatic dysfunction, defined as AST or ALT > 3 times the ULN.
16. Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m2.
17. BMI >35 kg/m2.
18. Nitrate intolerance
19. Contra-indication to heart rate lowering drugs.
20. Unable to provide written informed consent.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day 0 (day of the procedure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	day 0 (day of the procedure

Collaborators and Investigators

• Sponsor: CoreAalst BV
• Collaborators: HeartFlow, Inc.
• Investigators: Principal Investigator: Eric Wyffels, MD, PhD, OLV Hospital Aalst

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2023
• Primary Completion (Estimated): October 15, 2030
• Study Completion (Estimated): October 15, 2031

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: FFRCT
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: CA-063

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No