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Heart DiseaseIMPAGNCT02527044

Impact of Preoperative FFR on Arterial Bypass Graft Functionality

A study testing Fractional Flow Reserve (FFR) in people with Heart Disease, run by Ottawa Heart Institute Research Corporation at 2 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Disease
What is being tested?
Fractional Flow Reserve (FFR)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesin 2 countries
Study dates
Nov 2015to Nov 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Belgium1 site
  • Clinique Saint-Luc Bouge

    Bouge

Other trials in Belgium

Canada1 site
  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y4W7

Other trials in Canada

About this study

Official title: Impact of Preoperative FFR on Arterial Bypass Graft Functionality: Towards a New CABG Paradigm

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.

Read the detailed description

The objective of surgical coronary revascularization is to restore blood flow supply to a myocardial territory that is ischemic or at risk of infarction, by interposing a low-resistance conduit in parallel to a major diseased coronary artery segment. The conductance of this additional conduit must be sufficient to accommodate high flow demands with minimal pressure drop at the site of distal implantation. Such a conduit may be used either as single independent graft, or assembled in a variety of sequential configurations, according to the preferred technique and based on the underlying coronary artery disease (CAD). Saphenous vein grafts (SVGs), most commonly used as single free grafts reimplanted on the aorta, are large conduits with very limited vasomotion. Their resistance to blood flow is negligible due to their large diameter, absence of muscular layer and usually short length, but their long-term patency is hindered by the development of premature atherosclerosis. In contrast, arterial grafts are usually of smaller diameter and more resistive due to their histological features. These arterial conduits are usually used in situ, as the second or third order of branches from the aorta and, therefore, have higher pressure drops compared to grafts implanted directly onto the aorta. Alternatively, the creation of composite T grafts with the free right internal thoracic artery (RITA) connected to the in situ left internal thoracic artery (LITA) can allow revascularization of all myocardium at risk. However, consequences of such a combination are that the flow supply is entirely dependent on the flow capacity of the proximal LITA, and that resistance along the graft may become a concern, particularly at the more distal anastomoses of the configuration (due to the cumulative length and distal graft tapering).

Competitive flow typically occurs when the resistance of the graft closely matches that of the native coronary artery target. In this situation, both the native coronary artery and the bypass graft contribute to distal perfusion, each providing resistance to blood flow from the other. Schematically, these resistances are arranged in parallel with input pressure at the coronary ostium or at the ostium of the graft, and output pressure at the anastomotic target site. The pressures at the two ends of the circuit are identical with only minor phasic variations in proximal pressure due to the delay in progression of the systolic pressure wave from the coronary ostium to the more distal ostium of the graft. According to Ohm's law, blood flow is directly proportional to pressure gradient and inversely proportional to resistance. Consequently, the relative contribution of the graft and of the native circulation to distal perfusion will be inversely proportional to their own resistance: if the resistance of the graft exceeds that of the native vessel (for instance, in situations of non-severely obstructive CAD), the distal territory will be predominantly perfused by the native coronary artery; if the resistance of the native vessel remains higher, the flow through the graft will be predominant; if both conduits oppose near-identical resistances to flow, their contribution to distal blood flow will be equivalent.

Many reports have consistently suggested that competitive flow in arterial bypass grafts negatively affects patency: more graft failures are observed when native coronary stenosis is less severe. Further, the misunderstanding of competitive flow also impairs multiple arterial grafting adoption rates, which remain quite low worldwide despite proven superior outcomes, due in large part to incomplete understanding of the effects of flow competition by surgeons. Current methods to evaluate coronary stenosis are: visual inspection, quantitative computerized angiography (QCA) and fractional flow reserve (FFR). Several studies have compared these three methods, demonstrating that visual assessment and QCA are of limited value for accurately predicting the significance of most intermediate narrowings and, therefore, at predicting a competition phenomenon. In contrast, FFR measures the consequence of the stenosis in terms of reduction of blood flow capacity. FFR reliably identifies stenoses associated with inducible ischemia with more than 93% accuracy, a rate higher than any other test. Despite these advantages, FFR is not widely applied especially in coronary surgery whereas in interventional cardiology, it is used near systematically. What the investigators propose in this collaborative study is a complete paradigm shift in how coronary surgery is carried out - total arterial grafting supported by a true physiologic basis, and a correlated proof of its outcomes.

Currently, indications for surgical coronary revascularization still largely rely only on visual estimation of stenoses. Unfortunately, the estimation of the true coronary lesion severity by visual estimation is especially poor for moderate lesions, i.e. between 50 to 70% stenosis. An FFR cutoff value of 0.8 is obtained in only 35% of these moderate lesions. When using saphenous vein, the impact of competition flow on graft patency is minimal in this situation but when an artery conduit is preferred, it impacts the functionality of the graft significantly.

Therefore, the investigators are proposing a prospective FFR evaluation of surgical patients with 3-vessel CAD, whose disease severity will be estimated by visual inspection during diagnostic angiogram. FFR will be performed and all values will be recorded; however, the patient, interventional cardiologist, and surgeon will be blinded to its results. All patients will then undergo coronary surgery with planned arterial revascularization. Six months after surgery, a control angiogram will be performed to evaluate functionality of the grafts. The results of this functional assessment will be correlated with the preoperative FFR values, in order to find a cutoff above which the arterial grafts are not functional, which will also be analyzed by subgroups defined according to configuration (i.e. in situ or composite).

Conditions
Heart Disease
Being tested
Fractional Flow Reserve (FFR)
Keywords
Coronary Artery Bypass, Flow Reserve
Medical subject headings
Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fractional Flow Reserve (FFR)Procedure or surgery

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

Study groups in NCT02527044
Study groupRoleWhat they receive
Functional graftExperimentalFollow-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.
Receives: Procedure: Fractional Flow Reserve (FFR)
Non functional graftActive comparatorFollow-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.
Receives: Procedure: Fractional Flow Reserve (FFR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 12 months

Secondary outcomes (2)
  1. Correlation between pre-operative FFR and anastomosis occlusion

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

    Measured: Up to 12 months

  2. Major Adverse Cardiac Events

    Major adverse cardiac events (MACE) is a qualitative measurement of any adverse cardiac events such as death or myocardial infraction after the operative procedure.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionNov 2028 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02527044
Sponsor's protocol ID
4385
Acronym
IMPAG
Status last verified
Apr 2026
First submitted
11 Aug 2015
Last updated
1 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17174100
  • Glineur D, Djaoudi S, D'horre W, Gurne O, Delouvroy A, de Kerchove L, El Khoury G, Hanet C. Endothelium-dependent and endothelium-independent vasodilator response of left and right internal mammary and internal thoracic arteries used as a composite Y-graft. Eur J Cardiothorac Surg. 2011 Aug;40(2):389-93. doi: 10.1016/j.ejcts.2010.11.055. Epub 2011 Jan 28.

    PubMed 21277219
  • 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.

    PubMed 18824757
  • 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.

    PubMed 16159832
  • Lemma M, Innorta A, Pettinari M, Mangini A, Gelpi G, Piccaluga M, Danna P, Antona C. Flow dynamics and wall shear stress in the left internal thoracic artery: composite arterial graft versus single graft. Eur J Cardiothorac Surg. 2006 Apr;29(4):473-8. doi: 10.1016/j.ejcts.2006.01.035. Epub 2006 Mar 7.

    PubMed 16522367
  • 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.

    PubMed 23075821
  • Glineur D, Hanet C. Competitive flow and arterial graft a word of caution. Eur J Cardiothorac Surg. 2012 Apr;41(4):768-9. doi: 10.1093/ejcts/ezr064. Epub 2011 Nov 24. No abstract available.

    PubMed 22423057
  • 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.

    PubMed 22014339
  • 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.

    PubMed 18191734
  • Glineur D, Hanet C, D'hoore W, Poncelet A, De Kerchove L, Etienne PY, Noirhomme P, El Khoury G. Causes of non-functioning right internal mammary used in a Y-graft configuration: insight from a 6-month systematic angiographic trial. Eur J Cardiothorac Surg. 2009 Jul;36(1):129-35; discussion 135-6. doi: 10.1016/j.ejcts.2009.02.041. Epub 2009 Apr 15.

    PubMed 19372044
  • Sabik JF 3rd, Lytle BW, Blackstone EH, Khan M, Houghtaling PL, Cosgrove DM. Does competitive flow reduce internal thoracic artery graft patency? Ann Thorac Surg. 2003 Nov;76(5):1490-6; discussion 1497. doi: 10.1016/s0003-4975(03)01022-1.

    PubMed 14602274
  • White CW, Wright CB, Doty DB, Hiratza LF, Eastham CL, Harrison DG, Marcus ML. Does visual interpretation of the coronary arteriogram predict the physiologic importance of a coronary stenosis? N Engl J Med. 1984 Mar 29;310(13):819-24. doi: 10.1056/NEJM198403293101304.

    PubMed 6700670
  • Bursch JH, Hahne HJ, Brennecke R, Gronemeier D, Heintzen PH. Assessment of arterial blood flow measurements by digital angiography. Radiology. 1981 Oct;141(1):39-47. doi: 10.1148/radiology.141.1.7291540.

    PubMed 7291540
  • Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.

    PubMed 19144937
  • Nam CW, Mangiacapra F, Entjes R, Chung IS, Sels JW, Tonino PA, De Bruyne B, Pijls NH, Fearon WF; FAME Study Investigators. Functional SYNTAX score for risk assessment in multivessel coronary artery disease. J Am Coll Cardiol. 2011 Sep 13;58(12):1211-8. doi: 10.1016/j.jacc.2011.06.020.

    PubMed 21903052

Questions about this trial

What is this clinical trial studying?

A study testing Fractional Flow Reserve (FFR) in people with Heart Disease, run by Ottawa Heart Institute Research Corporation at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between pre-operative FFR and anastomosis function (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02527044, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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