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The COMPLETE Study

NCT06205810 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2026-01-20

No results posted yet for this study

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

Sponsors & Collaborators

  • HeartFlow, Inc.

    collaborator INDUSTRY

  • CoreAalst BV

    lead INDUSTRY

Principal Investigators

  • Eric Wyffels, MD, PhD · OLV Hospital Aalst

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-24
Primary Completion
2030-10-15
Completion
2031-10-15

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06205810 on ClinicalTrials.gov