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NCT03055780 Clinical Trial

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

Coronary Artery Disease Clinical Trial

Official title:
Clinical Trial for SURECardio CT-FFR

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03055780
Other study ID # SGD03-0667
Secondary ID
Status Completed
Phase N/A
First received February 14, 2017
Last updated February 14, 2017
Start date July 1, 2015
Est. completion date October 1, 2016

Study information
Verified date February 2017
Source Toshiba Medical Systems Corporation, Japan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 59
Est. completion date October 1, 2016
Est. primary completion date May 30, 2016
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CT-FFR. CTA. FFR
Study is to compare results of CT FFR against CTA and interventional FFR

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Toshiba Medical Systems Corporation, Japan

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity and specificity of SURECardio CT-FFR to detect functionally significant coronary stenosis one day
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