The COMPLETE Study
ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCoreAalst BV
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
STEMI.
Hemodynamic instability.
Rapid atrial fibrillation, flutter or arrhythmia (HR > 80 bpm).
Insufficient CCTA image quality.
Trial population
Patients with Coronary Artery Disease with an epicardial stenosis of more than 50% of visual assessment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
day 0 (day of the procedure)Secondary outcomes
1
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.
Time frame
day 0 (day of the procedure)2
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.
Time frame
day 0 (day of the procedure)3
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).
Time frame
day 0 (day of the procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
CoreAalst BV
Lead sponsor
HeartFlow, Inc.
Collaborator
Source ClinicalTrials.gov