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

• ClinicalTrials.gov Identifier: NCT03055780
• Recruitment Status: Completed
• First Posted: February 16, 2017
• Last Update Posted: February 16, 2017
• Sponsor: Toshiba Medical Systems Corporation, Japan
• 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

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

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