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

NCT ID: NCT00592228

Last Updated: 2010-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-01-31

Brief Summary

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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

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Conditions

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Coronary Angiography Drug-eluting Stents Fractional Flow Reserve, Myocardial

Keywords

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intermediate lesion drug-eluting stent fractional flow reserve

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Fractional flow guided drug-eluting stent implantation arm

Group Type OTHER

Cypher, Taxus or Endeavor

Intervention Type DEVICE

percutaneous drug-eluting stent implantation,

1. FFR group: if FFR\<0.75
2. Routine DES group

2

Routine drug-eluting stent implantation

Group Type OTHER

Cypher, Taxus or Endeavor

Intervention Type DEVICE

percutaneous drug-eluting stent implantation,

1. FFR group: if FFR\<0.75
2. Routine DES group

Interventions

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Cypher, Taxus or Endeavor

percutaneous drug-eluting stent implantation,

1. FFR group: if FFR\<0.75
2. Routine DES group

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Hospital

Principal Investigators

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Bon-Kwon Koo

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul national university hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Park SH, Jeon KH, Lee JM, Nam CW, Doh JH, Lee BK, Rha SW, Yoo KD, Jung KT, Cho YS, Lee HY, Youn TJ, Chung WY, Koo BK. Long-Term Clinical Outcomes of Fractional Flow Reserve-Guided Versus Routine Drug-Eluting Stent Implantation in Patients With Intermediate Coronary Stenosis: Five-Year Clinical Outcomes of DEFER-DES Trial. Circ Cardiovasc Interv. 2015 Dec;8(12):e002442. doi: 10.1161/CIRCINTERVENTIONS.115.002442.

Reference Type DERIVED
PMID: 26643736 (View on PubMed)

Other Identifiers

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H-0706-026-210

Identifier Type: -

Identifier Source: org_study_id