Coronary Angiography, Drug-eluting Stents, Fractional Flow Reserve, Myocardial
Conditions
Keywords
intermediate lesion, drug-eluting stent, fractional flow reserve
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.
Interventions
DEVICECypher, Taxus or Endeavor
percutaneous drug-eluting stent implantation, 1. FFR group: if FFR\<0.75 2. Routine DES group
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical event: Cardiac death, myocardial infarction, target lesion revascularization | 9 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IVUS | at the time of procedure | IVUS minimum lumen area |
Countries
South Korea
Outcome results
None listed