Main Branch Versus Side Branch Ostial Lesion

Coronary Artery Stenosis Clinical Trial

Official title:

Relationship Between Fractional Flow Reserve and Coronary Angiography/Intravascular Ultrasound Parameters in Ostial Lesions: Major Coronary Ostial Lesions Versus Side Branch Ostial Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335659
• Other study ID #: Bif_3
• Status: Completed
• Phase: N/A
• First received: April 7, 2011
• Last updated: July 20, 2011
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Coronary Artery Stenosis
• Coronary Stenosis

Intervention

Device:
• Fractional flow reserve
Fractional flow reserve measured by pressure wire
• IVUS
intravascular ultrasound :IVUS was performed in a standard fashion using an automated motorized pullback system (0.5mm/s) with commercially available imaging catheter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lumen area	lumen area at ostial lesion	1 day	No
Secondary	angiographic stenosis, % plaque area	angiographic and intravascular ultrasound parameters at ostial lesions of each major branch and side branch.	1 day	No