Study of the Natural History of FFR Guided Percutaneous Coronary Intervention (IRIS FFR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by CardioVascular Research Foundation, Korea
Sponsor:
Collaborators:
CardioVascular Research Foundation, Korea
St. Jude Medical
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01366404
First received: June 2, 2011
Last updated: February 5, 2016
Last verified: February 2016

June 2, 2011
February 5, 2016
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
 
Study of the Natural History of FFR Guided Percutaneous Coronary Intervention
A Multicenter, Prospective Cohort to Evaluate the Natural History of FFR Guided Percutaneous Coronary Intervention
About 10,000 patients with FFR (Fractional Flow Reserve) 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 10,000 patients with FFR will be enrolled at multi centers in Korea.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients who had FFR measurement
Coronary Artery Disease
Not Provided
FFR
Patients who had FFR measurement

*   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 35 years and older
  • FFR measurement on one and more coronary artery stenosis
  • Willing and able to provide informed, written consent

Exclusion Criteria:

  • Stenosis with TIMI<3 flow
  • Graft vessel
  • Ejection fraction < 30%
  • Angiographic evidence of extreme tortuosity or calcified coronary vessels
  • Suspected coronary spasm even after sufficient nitrate injected
  • Life expectancy <2 year
  • 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

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
35 Years and older   (Adult, Senior)
No
Contact: Seung-Jung Park, MD, PhD sjpark@amc.seoul.kr
Contact: Jung-min Ahn, MD drjmahn@gmail.com
Korea, Republic of
 
NCT01366404
CVRF2010-09
Yes
No
This is not publicly funded trial
Seung-Jung Park, CardioVascular Research Foundation, Korea
Seung-Jung Park
  • CardioVascular Research Foundation, Korea
  • St. Jude Medical
Principal Investigator: Seung-Jung Park, MD,PhD Asan Medical Center
CardioVascular Research Foundation, Korea
February 2016

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