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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03055780
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : February 16, 2017
Information provided by (Responsible Party):
Toshiba Medical Systems Corporation, Japan

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

Condition or disease Intervention/treatment
Coronary Artery Disease Device: CT-FFR. CTA. FFR

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.

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Study Type : Observational
Actual Enrollment : 59 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Trial for SURECardio CT-FFR
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : May 30, 2016
Actual Study Completion Date : October 1, 2016

Group/Cohort Intervention/treatment
59 patients with suspected CAD that have been scheduled for an interventional FFR study
Device: CT-FFR. CTA. FFR
Study is to compare results of CT FFR against CTA and interventional FFR

Primary Outcome Measures :
  1. Sensitivity and specificity of SURECardio CT-FFR to detect functionally significant coronary stenosis [ Time Frame: one day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Suspected coronary artery disease

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
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Responsible Party: Toshiba Medical Systems Corporation, Japan Identifier: NCT03055780    
Other Study ID Numbers: SGD03-0667
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases