Main Branch Versus Side Branch Ostial Lesion | NCT01335659

Studies
Main Branch Versus Side Branch Ostial Lesion

NCT01335659

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jul 21, 2011Estimated

Enrollment

77Actual

Phase

Not provided

Conditions

Coronary Artery Stenosis

Interventions

Fractional flow reserve
IVUS

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

Jul 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

Jun 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Apr 7, 2011

First Submission Date that Met QC Criteria

Apr 13, 2011

First Posted Date

Apr 14, 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

Jul 20, 2011

Last Update Posted Date

Jul 21, 2011Estimated

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 studied the relations between coronary angiography (CAG), intravascular ultrasound (IVUS) and fractional flow reserve (FFR) in coronary ostial lesions.

Detailed Description

Angiographic evaluation for ostial lesions is reported to be inaccurate in the assessment of the functional and clinical significance of a lesion. The investigators studied the relations between coronary angiography (CAG), intravascular ultrasound (IVUS) and fractional flow reserve (FFR) in coronary ostial lesions.

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

77Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ostial lesion		ostial lesion will be evaluated by IVUS and FFR	Device: Fractional flow reserve Device: IVUS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fractional flow reserve	Device	Fractional flow reserve measured by pressure wire	ostial lesion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
lumen area	lumen area at ostial lesion	1 day

Secondary Outcomes

Measure	Description	Time Frame
angiographic stenosis, % plaque area	angiographic and intravascular ultrasound parameters at ostial lesions of each major branch and side branch.	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 21-85
Presence of at least one obstructive coronary artery stenosis at coronary ostium as defined by:
Previous catheterization with any coronary ostium lesion 50% or greater
Ability and Willingness to provide informed consent
Ability and Willingness to perform required follow up procedures

Exclusion Criteria:

History of coronary artery bypass graft surgery
left main coronary ostial lesion
significant stenosis at proximal or distal part of coronary ostium lesion
ostial lesion related to infarcton
Creatinine>1.6 mg/dL or GFR<30 pre-procedure per institutional standards
Ejection fraction lower than 40%
Known Pregnancy
Arrhythmia
Contrast agent allergy that cannot be adequately premedicated
Patient not a candidate for IVUS and FFR
Inability or unwillingness to provide informed consent
Inability or unwillingness to perform required follow up procedures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

from september 2009 to january 2011 patient who are undergone coronary angiography,IVUS and FFR for the evaluation of coronary artery disease at SNUH

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bon-kwon Koo, MD/PhD	Seoul National University Hospital	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22516397	Derived	Koh JS, Koo BK, Kim JH, Yang HM, Park KW, Kang HJ, Kim HS, Oh BH, Park YB. Relationship between fractional flow reserve and angiographic and intravascular ultrasound parameters in ostial lesions: major epicardial vessel versus side branch ostial lesions. JACC Cardiovasc Interv. 2012 Apr;5(4):409-15. doi: 10.1016/j.jcin.2012.01.013.

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