Diagnostic Accuracy to Detect Hemodynamically Significant Stenosis by Non-invasive SURECardio CT-FFR

Clinical Trial for SURECardio CT-FFR

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03055780

Enrollment

Registered

2017-02-16

Start date

2015-07-01

Completion date

2016-10-01

Last updated

2017-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Brief summary

The aim of this study was to determine the diagnostic accuracy of SURECardio CT-FFR to detect functionally significant coronary stenosis.

Detailed description

CT acquision and invasive FFR measurement is performed for each patients. The diagnostic accuracy of coronary CTA and SURECardio CT-FFR is investigated using Invasive FFR is used as the reference standard.

Interventions

DEVICECT-FFR. CTA. FFR

Study is to compare results of CT FFR against CTA and interventional FFR

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* suspected coronary artery disease * hemodynamically stable condition

Exclusion criteria

* hemodynamic instability * atrial fibrillation * morbid obesity (BMI≥40 kg/m2) * previous stent implantation * recent myocardial infarction (within 30 days) * age \<40 years * renal insufficiency (eGFR \<60mL/min/1.73m2) * bronchospastic lung disease requiring long term steroid therapy

Design outcomes

Primary

Measure	Time frame
Sensitivity and specificity of SURECardio CT-FFR to detect functionally significant coronary stenosis	one day

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026