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

December 20, 2010 updated by: Seoul National University Hospital

Deferral of Angioplasty According to Fractional Flow Reserve vs. Routine Drug-eluting Stent Implantation in Intermediate Coronary Stenosis

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical event: Cardiac death, myocardial infarction, target lesion revascularization
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IVUS
Time Frame: at the time of procedure
IVUS minimum lumen area
at the time of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Anticipated)

January 1, 2009

Study Completion (Anticipated)

January 1, 2009

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

December 28, 2007

First Posted (Estimate)

January 11, 2008

Study Record Updates

Last Update Posted (Estimate)

December 21, 2010

Last Update Submitted That Met QC Criteria

December 20, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-0706-026-210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe