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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014