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Clinical Trials/NCT01366404
NCT01366404RecruitingNot Applicable

A Multicenter, Prospective Cohort to Evaluate the Natural History of FFR Guided Percutaneous Coronary Intervention

Seung-Jung Park29 sites in 1 country20,000 target enrollmentStarted: June 1, 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
20,000
Locations
29
Primary Endpoint
composite Cardiac Death,Non Fatal Myocardial Infarction, Target Vessel Revascularization, and Indeterminate events
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

About 20,000 patients with FFR (Fractional Flow Reserve) will be enrolled and evaluated for the natural history of coronary lesions at 2 years clinical and imaging follow-up.

Detailed Description

This is a multicenter, prospective cohort. About 20,000 patients with FFR will be enrolled at multi centres in Korea.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
35 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

composite Cardiac Death,Non Fatal Myocardial Infarction, Target Vessel Revascularization, and Indeterminate events

Time Frame: at 2 year after index FFR measurement

Target vessel failure

Time Frame: 2 year after index FFR measurement

Secondary Outcomes

  • stented lesion related event including death, myocardial infarction, repeat revascularization(2 year follow-up after index FFR measurement)
  • change in IVUS-measured MLA(2 year follow-up after index FFR measurement)
  • number of anti-anginal medication prescribed(2 year follow-up after index FFR measurement)
  • change in FFR(2 year follow-up after index FFR measurement)
  • Target lesion revascularization(at 2 year after index FFR measurement)
  • Any re-hospitalization with a cardiac cause(2 year follow-up after index FFR measurement)
  • cardiac death and myocardial infarction(2 year follow-up after index FFR measurement)
  • complication of FFR measurement(2 year follow-up after index FFR measurement)
  • Target vessel revascularization(at 2 year after index FFR measurement)
  • anginal status(2 year follow-up after index FFR measurement)
  • clinical predictors of events(2 year follow-up after index FFR measurement)
  • change in plaque composition (%necrotic core volume) in target segment(2 year follow-up after index FFR measurement)
  • change in plaque type assessed by VH(Virtual Histology) and OCT(Optical coherence tomography)(2 year follow-up after index FFR measurement)
  • Death (all cause and cardiac)(at 2 year after index FFR measurement)
  • MI(at 2 year after index FFR measurement)
  • stroke(2 year follow-up after index FFR measurement)
  • change in total atheroma volume and percent atheroma volume(2 year follow-up after index FFR measurement)
  • stent thrombosis(2 year follow-up after index FFR measurement)

Investigators

Sponsor
Seung-Jung Park
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Seung-Jung Park

Professor, Division of Cardiology

CardioVascular Research Foundation, Korea

Study Sites (29)

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