Impact of Preoperative FFR on Arterial Bypass Graft Functionality

NCT02527044 | Active Not Recruiting DMC

• 1 other identifier: 4385
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 2

Brief Summary

This study was designed to evaluate the correlation between pre-operative FFR and the functionality of arterial bypass grafts six months after coronary artery bypass grafting. Patients with multi-vessel coronary artery disease will undergo both a coronary angiogram and FFR during their diagnostic workup. All patients will be referred for surgical revascularization (CABG) with planned use of arterial grafts. Six months after surgery, patients will undergo an angiogram to assess the functionality of the bypass graft and anastomosis.

Conditions

Heart Disease

Keywords

Coronary Artery Bypass; Flow Reserve

Outcome Measures

Primary Outcomes (1)

• Correlation between pre-operative FFR and anastomosis function

  The primary outcome was the evaluation of the correlation between target vessel pre-operative FFR value and the anastomosis function as measured by angiogram approximately 6 months after surgery.

  Up to 12 months

Secondary Outcomes (2)

• Correlation between pre-operative FFR and anastomosis occlusion

  Up to 12 months

• Major Adverse Cardiac Events

  Up to 12 months

Study Arms (2)

Functional graft

EXPERIMENTAL

Follow-up angiography of all bypass grafts and anastomoses six months after surgery: anastomotic function was scored as 0 for an occluded graft, 1 when the flow from the native coronary artery was dominant, 2 when flow supply from the native coronary and from the graft was balanced, and 3 when the native coronary was fully opacified by the graft. An anastomosis was considered "functional" for score of 3.

Procedure: Fractional Flow Reserve (FFR)

Non functional graft

ACTIVE COMPARATOR

Follow-up angiography of all bypass grafts and anastomoses six months after surgery: anastomotic function was scored as 0 for an occluded graft, 1 when the flow from the native coronary artery was dominant, 2 when flow supply from the native coronary and from the graft was balanced, and 3 when the native coronary was fully opacified by the graft. An anastomosis was considered "non functional" for scores of 0 to 2.

Procedure: Fractional Flow Reserve (FFR)

Interventions

Fractional Flow Reserve (FFR) PROCEDURE

An FFR will be performed pre-operative to the CABG procedure

Functional graft; Non functional graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with multi-vessel coronary artery disease undergoing elective or urgent first time coronary artery bypass grafting (CABG).
• All patients undergoing diagnostic angiography and suspected to have multi-vessel disease for referral to CABG
• Patients requiring both on-pump or off-pump CABG are accepted, as long as a arterial revascularisation is planned.
• The patients must be over the age of 18.
• CABG is the only procedure being conducted

You may not qualify if:

• Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting)
• Redo CABG, or a percutaneous coronary intervention (PCI) within the last 6 months.
• Severe renal insufficiency (preoperative creatinine \>150umol/L) contraindicating postoperative coronary angiography
• Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
• Women who are pregnant or are seeking to become pregnant
• Must not have severe congestive heart failure (class III or IV New York Heart Association) at enrollment
• Left ventricular ejection fraction less than 30%
• Prior history of significant bleeding that might be expected to recur with CABG
• Prisoners or institutionalized individuals
• Geographic inaccessibility for the follow-up visits required by protocol
• Concurrent enrollment in another clinical trial
• Extra-cardiac illness that is expected to limit survival to less than 5 years

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (2)

Clinique Saint-Luc Bouge

Bouge, Belgium

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

Related Publications (30)

• Glineur D, Poncelet A, El Khoury G, D'hoore W, Astarci P, Zech F, Noirhomme P, Hanet C. Fractional flow reserve of pedicled internal thoracic artery and saphenous vein grafts 6 months after bypass surgery. Eur J Cardiothorac Surg. 2007 Mar;31(3):376-81. doi: 10.1016/j.ejcts.2006.11.023. Epub 2006 Dec 14.

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• Glineur D, Hanet C, Poncelet A, D'hoore W, Funken JC, Rubay J, Kefer J, Astarci P, Lacroix V, Verhelst R, Etienne PY, Noirhomme P, El Khoury G. Comparison of bilateral internal thoracic artery revascularization using in situ or Y graft configurations: a prospective randomized clinical, functional, and angiographic midterm evaluation. Circulation. 2008 Sep 30;118(14 Suppl):S216-21. doi: 10.1161/CIRCULATIONAHA.107.751933.

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• Glineur D, Noirhomme P, Reisch J, El Khoury G, Astarci P, Hanet C. Resistance to flow of arterial Y-grafts 6 months after coronary artery bypass surgery. Circulation. 2005 Aug 30;112(9 Suppl):I281-5. doi: 10.1161/CIRCULATIONAHA.104.524702.

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• Glineur D, Hanet C. Competitive flow in coronary bypass surgery: is it a problem? Curr Opin Cardiol. 2012 Nov;27(6):620-8. doi: 10.1097/HCO.0b013e3283583000.

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• Glineur D, D'hoore W, de Kerchove L, Noirhomme P, Price J, Hanet C, El Khoury G. Angiographic predictors of 3-year patency of bypass grafts implanted on the right coronary artery system: a prospective randomized comparison of gastroepiploic artery, saphenous vein, and right internal thoracic artery grafts. J Thorac Cardiovasc Surg. 2011 Nov;142(5):980-8. doi: 10.1016/j.jtcvs.2011.07.017.

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• Glineur D, D'hoore W, El Khoury G, Sondji S, Kalscheuer G, Funken JC, Rubay J, Poncelet A, Astarci P, Verhelst R, Noirhomme P, Hanet C. Angiographic predictors of 6-month patency of bypass grafts implanted to the right coronary artery a prospective randomized comparison of gastroepiploic artery and saphenous vein grafts. J Am Coll Cardiol. 2008 Jan 15;51(2):120-5. doi: 10.1016/j.jacc.2007.09.030.

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  PMID: 19144937 BACKGROUND

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MeSH Terms

Conditions

Heart Diseases

Interventions

Fractional Flow Reserve, Myocardial

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Coronary Circulation; Blood Circulation; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• David Glineur, MD, PhD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: FFR values are collected by a member of the research staff. The treating physicians, the patient, and the outcome assessor will be blinded to the pre-operative FFR values.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 18, 2015
• Study Start: November 1, 2015
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); BE (1)