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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:
ClinicalTrials.gov Identifier:
NCT00592228
First Posted: January 11, 2008
Last Update Posted: December 21, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Seoul National University Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • IVUS [ Time Frame: at the time of procedure ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bon-Kwon Koo, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00592228     History of Changes
Other Study ID Numbers: H-0706-026-210
First Submitted: December 17, 2007
First Posted: January 11, 2008
Last Update Posted: December 21, 2010
Last Verified: December 2010

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