Diagnostic Accuracy to Detect Hemodynamically Significant... | NCT03055780

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

NCT03055780

Sponsor

Toshiba Medical Systems Corporation, Japan

Status

Completed

Last Update Posted

Feb 16, 2017Actual

Enrollment

59Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

CT-FFR. CTA. FFR

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2015Actual

Primary Completion Date

May 30, 2016Actual

Completion Date

Oct 1, 2016Actual

First Submitted Date

Feb 14, 2017

First Submission Date that Met QC Criteria

Feb 14, 2017

First Posted Date

Feb 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2017

Last Update Posted Date

Feb 16, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CT-FFR. CTA. FFR		59 patients with suspected CAD that have been scheduled for an interventional FFR study	Device: CT-FFR. CTA. FFR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT-FFR. CTA. FFR	Device	Study is to compare results of CT FFR against CTA and interventional FFR	CT-FFR. CTA. FFR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity and specificity of SURECardio CT-FFR to detect functionally significant coronary stenosis		one day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Suspected coronary artery disease

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided