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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.
 
ClinicalTrials.gov Identifier: NCT03055780
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Toshiba Medical Systems Corporation, Japan

Tracking Information
First Submitted Date February 14, 2017
First Posted Date February 16, 2017
Last Update Posted Date February 16, 2017
Actual Study Start Date July 1, 2015
Actual Primary Completion Date May 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 14, 2017)
Sensitivity and specificity of SURECardio CT-FFR to detect functionally significant coronary stenosis [ Time Frame: one day ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnostic Accuracy to Detect Hemodynamically Significant Stenosis by Non-invasive SURECardio CT-FFR
Official Title Clinical Trial for SURECardio CT-FFR
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Suspected coronary artery disease
Condition Coronary Artery Disease
Intervention Device: CT-FFR. CTA. FFR
Study is to compare results of CT FFR against CTA and interventional FFR
Study Groups/Cohorts CT-FFR. CTA. FFR
59 patients with suspected CAD that have been scheduled for an interventional FFR study
Intervention: Device: CT-FFR. CTA. FFR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 14, 2017)
59
Original Actual Enrollment Same as current
Actual Study Completion Date October 1, 2016
Actual Primary Completion Date May 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03055780
Other Study ID Numbers SGD03-0667
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Toshiba Medical Systems Corporation, Japan
Study Sponsor Toshiba Medical Systems Corporation, Japan
Collaborators Not Provided
Investigators Not Provided
PRS Account Toshiba Medical Systems Corporation, Japan
Verification Date February 2017