Proper Fractional Flow Reserve Criteria for Intermediate Lesions in the Era of Drug-eluting Stent

Not Applicable

Terminated

• Conditions: Coronary Angiography; Drug-eluting Stents; Fractional Flow Reserve, Myocardial
• Interventions: Device: Cypher, Taxus or Endeavor

• Registration Number: NCT00592228
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Angiographic evaluation for intermediate lesions is not always accurate. Fractional flow reserve-guided deferral strategy for these lesions showed the same event rate as routine intervention strategy. However, proper FFR criterion for these lesions in the era of drug-eluting stent is not known. This study sought to evaluate the clinical outcomes of intermediate lesions according to FFR and compare those of FFR-guided intervention with routine drug-eluting stent implantation strategy.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-12-17
• Study First Submitted QC: 2007-12-28
• Study First Posted: 2008-01-11
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-20
• Last Update Posted: 2010-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Elective PCI
• Angiographically intermediate stenosis (50-75% by visual estimation) in native major coronary arteries, proximal and mid (branch, distal lesion: exclusion)
• Reference diameter > 2.5mm, lesion length < 60mm (cover by 2 stents)
• No documented evidence of ischemia by noninvasive tests

Exclusion Criteria

• Acute ST elevation MI
• Left main disease
• Chronic renal failure (cr >2 mg/dL)
• Expected survival < 2yrs
• > 1degree AV block

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cypher, Taxus or Endeavor	Fractional flow guided drug-eluting stent implantation arm
2	Cypher, Taxus or Endeavor	Routine drug-eluting stent implantation

Primary Outcome Measures

Name	Time	Method
Clinical event: Cardiac death, myocardial infarction, target lesion revascularization	9 months

Secondary Outcome Measures

Name	Time	Method
IVUS	at the time of procedure	IVUS minimum lumen area

Trial Locations

Locations (1)

Seoul national university hospital; 🇰🇷 Seoul, Korea, Republic of