The COMPLETE Study | NCT06205810

Studies
The COMPLETE Study

NCT06205810

Sponsor

CoreAalst BV

Status

Recruiting

Last Update Posted

Jan 20, 2026Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 24, 2023Actual

Primary Completion Date

Oct 15, 2030Estimated

Completion Date

Oct 15, 2031Estimated

First Submitted Date

Nov 28, 2023

First Submission Date that Met QC Criteria

Jan 3, 2024

First Posted Date

Jan 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2026

Last Update Posted Date

Jan 20, 2026Actual

Name	Class
HeartFlow, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sofie Pardaens, MSc, PhD	Contact	0032 53 72 42 30		sofiepardaens@coreaalst.com

Overall Officials

Name	Affiliation	Role
Eric Wyffels, MD, PhD	OLV Hospital Aalst	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OLV Hospital Aalst	Recruiting	Aalst	Oost-Vlaanderen	9300	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

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Browse Branches

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