The COMPLETE Study

NCT06205810 | Recruiting

• 1 other identifier: CA-063
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Coronary Artery Disease

Keywords

FFRCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  day 0 (day of the procedure)

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

  day 0 (day of the procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• \. Epicardial stenosis more than 50% by visual assessment.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CoreAalst BV: lead
• HeartFlow, Inc.: collaborator

Study Sites (1)

OLV Hospital Aalst

Aalst, Oost-Vlaanderen, 9300, Belgium

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Eric Wyffels, MD, PhD

  OLV Hospital Aalst

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofie Pardaens, MSc, PhD

CONTACT

0032 53 72 42 30; sofiepardaens@coreaalst.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: January 16, 2024
• Study Start: October 24, 2023
• Primary Completion (Estimated): October 15, 2030
• Study Completion (Estimated): October 15, 2031
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

BE (1)