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

This study is currently recruiting participants.
Verified August 2012 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: August 7, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter, Prospective Cohort to Evaluate The Natural History of FFR Guided Deferred Lesions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 2000
Study Start Date: June 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
FFR Deferred
Patients who had FFR measurement with visual estimated diameter stenosis of >30% and FFR value of >0.80

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366404

Contacts
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

Locations
Korea, Republic of
28 Locations Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seung-Jung Park, MD,PhD Asan Medical Center
  More Information

No publications provided by CardioVascular Research Foundation, Korea

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Seung-Jung Park, MD,PhD, Chairman of Heart Institution, Asan Medical Center, University of Ulsan College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT01366404     History of Changes
Other Study ID Numbers: CVRF2010-09
Study First Received: June 2, 2011
Last Updated: August 7, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by CardioVascular Research Foundation, Korea:
Deferred Lesion by FFR

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013