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

Seoul National University

Status: Terminated

Conditions: Coronary Angiography; Fractional Flow Reserve, Myocardial; Drug-eluting Stents

Treatments: Device: Cypher, Taxus or Endeavor

Study type: Interventional

Funder types: Other

Identifiers

NCT00592228

H-0706-026-210

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

1

Other group

Description:

Fractional flow guided drug-eluting stent implantation arm

Treatment:

Device: Cypher, Taxus or Endeavor

2

Other group

Description:

Routine drug-eluting stent implantation

Treatment:

Device: Cypher, Taxus or Endeavor