Graft Patency After FFR-guided Versus Angio-guided CABG (GRAFFITI) Trial (GRAFFITI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified March 2013 by Emanuele Barbato, Onze Lieve Vrouw Hospital.
Recruitment status was: Recruiting

Sponsor:

Information provided by (Responsible Party):

Emanuele Barbato, Onze Lieve Vrouw Hospital

ClinicalTrials.gov Identifier:

NCT01810224

First received: March 9, 2013

Last updated: March 11, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 9, 2013

Last Updated Date

March 11, 2013

Start Date ^ICMJE

March 2013

Estimated Primary Completion Date

December 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Rate of occluded bypass grafts [ Time Frame: 1 year ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Graft Patency After FFR-guided Versus Angio-guided CABG (GRAFFITI) Trial

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

Procedure: Surgical revascularization

The final intervention (surgical revascularization) will be the same for both arms.

Study Arms

Active Comparator: Angio-guided arm
In this arm will be included the patient randomized to a Angiography-guided surgical revascularization strategy.

Intervention: Procedure: Surgical revascularization
Experimental: FFR-guided arm
In this arm will be included the patient randomized to a FFR-guided surgical revascularization strategy.

Intervention: Procedure: Surgical revascularization

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

206

Completion Date

Not Provided

Estimated Primary Completion Date

December 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 90 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Belgium, Czech Republic, Hungary

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01810224

Other Study ID Numbers ^ICMJE

GRAFFITI

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Emanuele Barbato, Onze Lieve Vrouw Hospital

Study Sponsor ^ICMJE

Onze Lieve Vrouw Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Emanuele Barbato, MD, PhD

Cardiovascular Center Aalst, OLV Hospital, Aalst (Belgium)

PRS Account

Onze Lieve Vrouw Hospital

Verification Date

March 2013

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

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