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

Coronary Angiography Clinical Trial

— DEFER-DES  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00592228
• Other study ID #: H-0706-026-210
• Status: Terminated
• Phase: N/A
• First received: December 17, 2007
• Last updated: December 20, 2010
• Start date: January 2007
• Est. completion date: January 2009

Study information

• Verified date: December 2010
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 250
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Angiography
• Drug-eluting Stents
• Fractional Flow Reserve, Myocardial

Intervention

Device:
• Cypher, Taxus or Endeavor
percutaneous drug-eluting stent implantation, FFR group: if FFR<0.75 Routine DES group

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical event: Cardiac death, myocardial infarction, target lesion revascularization		9 months	No
Secondary	IVUS	IVUS minimum lumen area	at the time of procedure	No