NCT00592228

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

December 21, 2010

Status Verified

December 1, 2010

Enrollment Period

2 years

First QC Date

December 17, 2007

Last Update Submit

December 20, 2010

Conditions

Coronary AngiographyDrug-eluting StentsFractional Flow Reserve, Myocardial

Keywords

intermediate lesiondrug-eluting stentfractional flow reserve

Outcome Measures

Primary Outcomes (1)

  • Clinical event: Cardiac death, myocardial infarction, target lesion revascularization

    9 months

Secondary Outcomes (1)

  • IVUS

    at the time of procedure

Study Arms (2)

1

OTHER

Fractional flow guided drug-eluting stent implantation arm

Device: Cypher, Taxus or Endeavor

2

OTHER

Routine drug-eluting stent implantation

Device: Cypher, Taxus or Endeavor

Interventions

Cypher, Taxus or EndeavorDEVICE

percutaneous drug-eluting stent implantation, 1. FFR group: if FFR\<0.75 2. Routine DES group

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective PCI
  • Reference diameter \> 2.5mm, lesion length \< 60mm (cover by 2 stents)
  • No documented evidence of ischemia by noninvasive tests

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national university hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 26643736DERIVED

Study Officials

  • Bon-Kwon Koo

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 17, 2007

First Posted

January 11, 2008

Study Start

January 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

December 21, 2010

Record last verified: 2010-12

Locations

KR(1)