Virtual Coronary Intervention and Non-invasive Fractional... | NCT01478100

Studies
Virtual Coronary Intervention and Non-invasive Fractional Flow Reserve (FFR)

NCT01478100

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Nov 23, 2011Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

Countries

South Korea

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

Nov 2011

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

Oct 2011

Primary Completion Date

Nov 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Nov 20, 2011

First Submission Date that Met QC Criteria

Nov 22, 2011

First Posted Date

Nov 23, 2011Estimated

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

Nov 22, 2011

Last Update Posted Date

Nov 23, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bon-Kwon Koo, Associate Professor of Medicine, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators examined the feasibility of treatment planning using virtual coronary revascularization and fractional flow reserve (FFR) CT before the invasive procedures.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

20Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Significant stenosis at CT angiography
Normal ejection fraction on echocardiography
Informed consented patient

Exclusion Criteria:

Total occlusion and collateral flow to target vessel
AV conduction abnormality
Left ventricular hypertrophy
Significant valvular heart or primary myocardial disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

From the DISCOVER-FLOW study 20 patients with available post-intervention FFR were included in this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24332418	Derived	Kim KH, Doh JH, Koo BK, Min JK, Erglis A, Yang HM, Park KW, Lee HY, Kang HJ, Kim YJ, Lee SY, Kim HS. A novel noninvasive technology for treatment planning using virtual coronary stenting and computed tomography-derived computed fractional flow reserve. JACC Cardiovasc Interv. 2014 Jan;7(1):72-8. doi: 10.1016/j.jcin.2013.05.024. Epub 2013 Dec 11.

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