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

Toshiba Medical Systems

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: CT-FFR. CTA. FFR

Study type: Observational

Funder types: Industry

Identifiers

NCT03055780

SGD03-0667

Details and patient eligibility

About

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

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 40+ years old

Volunteers: No 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

Trial design

59 participants in 1 patient group

CT-FFR. CTA. FFR

Description:

59 patients with suspected CAD that have been scheduled for an interventional FFR study

Treatment:

Device: CT-FFR. CTA. FFR