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

This study has been terminated.
(due to slow enrollment)
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00592228
First received: December 17, 2007
Last updated: December 20, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention
Coronary Angiography
Drug-eluting Stents
Fractional Flow Reserve, Myocardial
Device: Cypher, Taxus or Endeavor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Deferral of Angioplasty According to Fractional Flow Reserve vs. Routine Drug-eluting Stent Implantation in Intermediate Coronary Stenosis

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Clinical event: Cardiac death, myocardial infarction, target lesion revascularization [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IVUS [ Time Frame: at the time of procedure ] [ Designated as safety issue: No ]
    IVUS minimum lumen area


Estimated Enrollment: 250
Study Start Date: January 2007
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Fractional flow guided drug-eluting stent implantation arm
Device: Cypher, Taxus or Endeavor

percutaneous drug-eluting stent implantation,

  1. FFR group: if FFR<0.75
  2. Routine DES group
2
Routine drug-eluting stent implantation
Device: Cypher, Taxus or Endeavor

percutaneous drug-eluting stent implantation,

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592228

Locations
Korea, Republic of
Seoul national university hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Bon-Kwon Koo Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Bon-Kwon Koo, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00592228     History of Changes
Other Study ID Numbers: H-0706-026-210
Study First Received: December 17, 2007
Last Updated: December 20, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
intermediate lesion
drug-eluting stent
fractional flow reserve

ClinicalTrials.gov processed this record on April 15, 2014