Outcome of FFR-guided Intervention Strategy | NCT01409577

Studies
Outcome of FFR-guided Intervention Strategy

NCT01409577

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Nov 22, 2011Estimated

Enrollment

1,500Estimated

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

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Dec 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Aug 2, 2011

First Submission Date that Met QC Criteria

Aug 3, 2011

First Posted Date

Aug 4, 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 19, 2011

Last Update Posted Date

Nov 22, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bon-Kwon Koo, Associate professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Name	Class
Ajou University	OTHER
Keimyung University Dongsan Medical Center	OTHER
Inje University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 investigator will evaluate the clinical outcomes of the patients in whom the treatment strategy for their coronary stenosis were determined by fractional flow reserve measurement.

Detailed Description

Inclusion criteria

Coronary stenosis
Successful measurement of fractional flow reserve

Clinical outcomes

Death
Cardiac death
Target lesion revascularization
Target vessel revascularization

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

1,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FFR		Patients with intermediate coronary stenosis Patients with successful fractional flow measurement Feasible > 9months clinical follow-up

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Long-term MACE	Cardiac death, MI, target vessel revascularization, target lesion revascularization	5 years

Secondary Outcomes

Measure	Description	Time Frame
Short-term MACE	Cardiac death, MI, TLR/TVR	9 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Coronary stenosis
Successful fractional flow reserve measurement

Exclusion Criteria:

Contraindication to adenosine
Expected life expectance < 1year

Accepts Healthy Volunteers

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

Patients with intermediate coronary stenosis by visual estimation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bon-Kwon Koo, MD, PhD	Contact	82-2-2072-2062		bkkoo@snu.ac.kr

Overall Officials

Name	Affiliation	Role
Bon-Kwon Koo, MD, PhD	Seoul National University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ilsan Paik hospital	Recruiting	Ilsan			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D023921	Coronary Stenosis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided