Natural History of FFR-Guided Deferred Coronary Lesions (IRIS FFR-DEFER Registry)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by CardioVascular Research Foundation, Korea
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01366404
First received: June 2, 2011
Last updated: October 9, 2014
Last verified: October 2014

June 2, 2011
October 9, 2014
June 2011
June 2017   (final data collection date for primary outcome measure)
  • Target vessel failure [ Time Frame: 2 year after index FFR measurement ] [ Designated as safety issue: Yes ]
  • composite Cardiac Death,Non Fatal Myocardial Infarction, Target Vessel Revascularization, and Indeterminate events [ Time Frame: at 2 year after index FFR measurement ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01366404 on ClinicalTrials.gov Archive Site
  • Death (all cause and cardiac) [ Time Frame: at 2 year after index FFR measurement ] [ Designated as safety issue: Yes ]
  • MI [ Time Frame: at 2 year after index FFR measurement ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization [ Time Frame: at 2 year after index FFR measurement ] [ Designated as safety issue: No ]
  • Target lesion revascularization [ Time Frame: at 2 year after index FFR measurement ] [ Designated as safety issue: No ]
  • Any re-hospitalization with a cardiac cause [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: Yes ]
  • cardiac death and myocardial infarction [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: Yes ]
  • stented lesion related event including death, myocardial infarction, repeat revascularization [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: Yes ]
  • stroke [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: Yes ]
  • stent thrombosis [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: Yes ]
  • anginal status [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: Yes ]
  • number of anti-anginal medication prescribed [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: No ]
  • complication of FFR measurement [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: No ]
  • clinical predictors of events [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: Yes ]
  • change in plaque composition (%necrotic core volume) in target segment [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: No ]
  • change in plaque type assessed by VH(Virtual Histology) and OCT(Optical coherence tomography) [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: No ]
  • change in total atheroma volume and percent atheroma volume [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: No ]
  • change in IVUS-measured MLA [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: No ]
  • change in FFR [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: No ]
  • Death (all cause and cardiac) [ Time Frame: at 2 year after index FFR measurement ] [ Designated as safety issue: Yes ]
  • MI [ Time Frame: at 2 year after index FFR measurement ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Natural History of FFR-Guided Deferred Coronary Lesions (IRIS FFR-DEFER Registry)
A Multicenter, Prospective Cohort to Evaluate The Natural History of FFR Guided Deferred Lesions

About 5,000 patients with coronary angiography performed have at least one coronary stenosis with visual estimated diameter stenosis of >30% and FFR (Fractional Flow Reserve) value of >0.80 will be enrolled and evaluated for the natural history of coronary lesions at 2 year clinical and imaging follow-up.

This is a multicenter, prospective cohort. About 5,000 patients who performed coronary angiography and have at least one coronary stenosis with visual estimated diameter stenosis of >30% and FFR value of >0.80 will be enrolled at 30 centers in Korea. Brief study design is as depicted in the following figure.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients who had FFR measurement and the lesion deferred by FFR value of >0.80

Coronary Artery Disease
Not Provided
FFR Deferred
Patients who had FFR measurement with visual estimated diameter stenosis of >30% and FFR value of >0.80

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10000
June 2017
June 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 years of older
  • Any major epicardial coronary artery* with angiographic diameter stenosis of >30% by visual estimation and with FFR value of >0.80
  • Willing and able to provide informed, written consent

Exclusion Criteria:

  • Stenosis with TIMI<3 flow
  • Infarct related artery within 5 days
  • Graft vessel
  • Ejection fraction < 30%
  • Angiographic evidence of extreme tortuosity or calcified coronary vessels
  • Stented vessel
  • Suspected coronary spasm even after sufficient nitrate injected
  • Life expectancy <2y
  • Planned cardiac surgery or planned major non cardiac surgery
  • Woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study

DEFER imaging study specific exclusion criteria

  • visually-estimated angiographic reference segment diameter of <2.75mm or >4.0mm
  • Inappropriate for IVUS/VH/OCT procedures. inability for imaging wire or catheter to pass through the tight stenosis, severe calcification, angulation
Both
19 Years and older
No
Contact: Seung-Jung Park, MD, PhD 82-2-3010-4812 sjpark@amc.seoul.kr
Contact: Duk-Woo Park, MD, PhD 82-2-3010-4812 dwpark@amc.seoul.kr
Korea, Republic of
 
NCT01366404
CVRF2010-09
Yes
Seung-Jung Park, CardioVascular Research Foundation, Korea
Seung-Jung Park
CardioVascular Research Foundation, Korea
Principal Investigator: Seung-Jung Park, MD,PhD Asan Medical Center
CardioVascular Research Foundation, Korea
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP