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Clinical Trials/NCT01810224
NCT01810224UnknownPhase 4

Graft Patency After FFR-guided Versus Angio-guided CABG: a Prospective, Multicenter, Multinational, Randomized (1:1) Controlled Trial

Onze Lieve Vrouw Hospital4 sites in 3 countries206 target enrollmentStarted: March 1, 2013Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Sponsor
Enrollment
206
Locations
4
Primary Endpoint
Rate of occluded bypass grafts
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This is prospective, randomized, multicenter, multinational, randomized (1:1) study. The aim of this study is to assess the importance of functional assessment of coronary artery disease prior to bypass surgery. In particular, an FFR-guided strategy will be compared to the traditional Angio-guided strategy in the guidance of surgical revascularization by aorto-coronary bypass grafting.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with stable angina, unstable angina or NSTEMI candidate to CABG
  • •Significant LAD and/or LM lesion - proved by FFR or Angiography AND
  • •At least one more, angiographycally intermediate lesion

Exclusion Criteria

  • •Significant valvular disease with indication to surgical replacement
  • •Severe left ventricular dysfunction (EF<35%)
  • •Acute STEMI
  • •Atrial fibrillation, if Maze procedure is planned

Outcomes

Primary Outcomes

Rate of occluded bypass grafts

Time Frame: 1 year

Secondary Outcomes

  • a) Lenght of hospital stay; b) Changes in surgical strategy: i.e. open-chest surgery vs. mini-thoracotomy; extensive surgery versus minimal invasive approaches.(participants will be followed for the duration of hospital stay, an expected average of 3-4 weeks)

Investigators

Sponsor
Onze Lieve Vrouw Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Emanuele Barbato

Doctor

Onze Lieve Vrouw Hospital

Study Sites (4)

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