Outcome of FFR-guided Intervention Strategy

Coronary Artery Disease Clinical Trial

Official title:

Clinical Outcome of Fractional Flow Reserve-guided Coronary Intervention Strategy in Koreans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01409577
• Other study ID #: H1102-032-350
• Status: Recruiting
• Phase: N/A
• First received: August 2, 2011
• Last updated: November 19, 2011
• Start date: March 2011
• Est. completion date: December 2011

Study information

• Verified date: November 2011
• Source: Seoul National University Hospital
• Contact: Bon-Kwon Koo, MD, PhD
• Phone: 82-2-2072-2062
• Email: bkkoo[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial 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.

Description:

Inclusion criteria

• Coronary stenosis

• Successful measurement of fractional flow reserve

Clinical outcomes

• Death

• Cardiac death

• Target lesion revascularization

• Target vessel revascularization

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Coronary stenosis

• Successful fractional flow reserve measurement

Exclusion Criteria:

• Contraindication to adenosine

• Expected life expectance < 1year

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Korea, Republic of	Ilsan Paik hospital	Ilsan
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ajou University, Inje University, Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term MACE	Cardiac death, MI, target vessel revascularization, target lesion revascularization	5 years	No
Secondary	Short-term MACE	Cardiac death, MI, TLR/TVR	9 months	No