Composite Arterial and Venous Grafting Strategy Versus Conventional Coronary Artery Bypass Grafting (AMI-PONT)

This study is currently recruiting participants.
Verified June 2012 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Information provided by (Responsible Party):
Louis-Mathieu Stevens, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01585285
First received: April 24, 2012
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

The purpose of the AMI-PONT trial is to assess whether the results in term of graft patency with a novel coronary artery bypass (CABG) strategy, including a saphenous vein bridge to distribute the arterial flow of the left anterior mammary artery (LIMA) to all the anterolateral territory, are not inferior than a conventional CABG strategy combining separated LIMA graft to left anterior descending coronary and vein graft for other target vessels of the anterolateral territory.


Condition Intervention
Coronary Artery Disease
Procedure: LIMA to SVG Bridge Technique
Procedure: Conventional CABG

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Noninferiority Randomized Clinical Trial Comparing Composite CABG Using Left Internal Mammary Artery and Saphenous Vein Graft Bridge to Distribute Arterial Flow to Anterolateral Territory Versus Conventional CABG Strategy

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • Anterolateral territory graft patency index [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Proportion of patent (non-occluded) distal anastomoses out of the total number of distal anastomoses for anterolateral distribution including the LAD and the other anterolateral territory coronary target assessed by multi-slice computed tomography angiography for all patients


Secondary Outcome Measures:
  • Assessment of grafts patency taken separately [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    LIMA to LAD graft patency will be specifically assessed in both groups. Since the grafting strategy provides direct perfusion of the LAD by anastomosing on the hood of the SVG anastomosis to the LAD, we do not expect to see a difference between groups for the expected superior LIMA-LAD patency

  • Composite clinical outcome [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: Yes ]
    Occurrence of the composite outcome of total mortality, stroke, nonfatal myocardial infarction, or target vessel revascularization (i.e. redo CABG surgery or percutaneous coronary intervention). Each clinical outcome will also be assessed separately.

  • Cardiovascular mortality [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: Yes ]
    Cardiovascular (CV) mortality: all deaths after the first 30 days are considered CV deaths unless a specific non-cardiovascular cause is evident and considered to be the cause of death (e.g. malignancy). Furthermore, patients who die during the index hospitalization but after the initial 30 days period (i.e. long ICU stay with sepsis) will be considered as CV deaths.

  • Recurrence of angina [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
    Recurrence of angina: new onset of typical chest angina with documented ischemia by stress testing (ECG, echocardiography, or nuclear) or persistence of CCS grade ≥2 angina after surgery.


Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LIMA to SVG Bridge
Coronary artery bypass grafting (CABG) strategy with left internal mammary artery (LIMA) to saphenous vein graft (SVG) Bridge to distribute the LIMA outflow to the left anterior descending (LAD) and other anterolateral territory targets
Procedure: LIMA to SVG Bridge Technique
This surgical design use a composite-sequential venous graft to distribute left internal mammary artery (LIMA) inflow directly to the left anterior descending (LAD), but also to the other branches of the anterolateral territory thereby promoting a higher flow through the LIMA pedicle. It is constructed using a short saphenous vein graft (SVG) bridge interposed between the LAD and one (or more) other anterolateral targets, with the LIMA grafted on the hood of the SVG just above the LAD anastomosis.
Active Comparator: Conventional CABG
Conventional coronary artery bypass grafting (CABG) strategy with left internal mammary artery (LIMA) graft to the left anterior descending (LAD) and separate sequential aorto-coronary saphenous vein grafts (SVG) to the others anterolateral targets
Procedure: Conventional CABG
Conventional coronary artery bypass grafting (CABG) strategy with left internal mammary artery (LIMA) graft to the left anterior descending (LAD) and separate sequential aorto-coronary saphenous vein grafts (SVG) to the others anterolateral targets

Detailed Description:

Purpose: This novel surgical design use a composite-sequential venous graft to distribute left anterior mammary artery (LIMA) inflow directly to the left anterior descending coronary (LAD), but also to the other branches of the anterolateral territory thereby promoting a higher flow through the LIMA pedicle. It is constructed using a short saphenous vein graft (SVG) bridge (LSVB) interposed between the LAD and one (or more) other anterolateral targets, with the LIMA grafted on the hood of the SVG just above the LAD anastomosis.

Objectives. The main objective of the prospective randomized clinical trial AMI-PONT is to assess whether a CABG strategy including a LSVB to distribute the LIMA outflow provides non-inferior patency rates compared to conventional CABG surgery with separated LIMA graft to LAD and SVG to other anterolateral targets.

Methods. Two hundred adult patients undergoing primary isolated CABG, requiring grafting of LAD and at least one other anterolateral target, will be randomized 1:1 in two treatment arms: 1) CABG strategy with LSVB; and 2) conventional CABG strategy with LIMA graft to the LAD and separate aorto-coronary SVG to other anterolateral targets. Patients will be assessed at 30 days, 6 months and one year. They will undergo graft patency assessment at one year using Multi-Slice Computed Tomography. All patients will undergo CABG using cardiopulmonary bypass (CPB). Patients will be excluded if they have a contraindication to CPB or MSCT graft assessment.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Patients who undergo coronary artery bypass grafting (CABG) surgery (for single, double or triple vessel disease) will be eligible if they:

  1. require isolated CABG with median sternotomy on at least one left anterior descending (LAD) site and another anterolateral target;
  2. provide written informed consent;
  3. are more than 21 years of age.

Exclusion Criteria: A patient will be excluded from the study if he/she does not fulfill the inclusion criteria, the patient or the treating physician refuse the study or if any of the following are observed:

  1. concomitant cardiac procedure associated with CABG including valve surgery and ascending aorta surgery;
  2. contra-indications to cardiopulmonary bypass (calcified aorta);
  3. unusable left internal mammary artery (LIMA) such as uncorrected subclavian artery stenosis, anterior chest trauma, radiation or injury during harvesting precluding the use of the LIMA;
  4. concomitant life-threatening disease likely to limit life expectancy to less than 2 years;
  5. emergency CABG surgery (immediate revascularization for hemodynamic instability precluding patient consent);
  6. prior CABG;
  7. severe congestive heart failure with left ventricular ejection fraction less than 30%.

    Other exclusion criteria precluding MSCT include:

  8. moderate to severe renal impairment (estimated glomerular filtration rate, eGFR <50 mL/min/1.73 m2);
  9. chronic atrial fibrillation (which can preclude ECG-gating during MSCT);
  10. history of severe hypersensitivity to iodinated contrast agents;
  11. known or suspected for pheochromocytoma;
  12. pregnant/lactating female.

    Furthermore, patients may be excluded at the time of MSCT if they are:

  13. in persistent rapid (>100/min) atrial fibrillation or any other cardiac rhythm that precludes reliable ECG triggering;
  14. severe congestive heart failure, New York Heart Association (NYHA) Class IV, despite coronary revascularization and maximal medical treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01585285

Contacts
Contact: Louis-Mathieu Stevens, MD, PhD (c) 514-890-8131 lm.stevens@videotron.ca
Contact: Joannie Dionne, MSc 514-890-8000 ext 14362 joannie.dionne.chum@ssss.gouv.qc.ca

Locations
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal (CHUM) Recruiting
Montreal, Quebec, Canada, H2W1T8
Contact: Louis-Mathieu Stevens, MD, PhD (c)    514-890-8131    lm.stevens@videotron.ca   
Contact: Joannie Dionne, MSc    514-890-8000 ext 14362    joannie.dionne.chum@ssss.gouv.qc.ca   
Principal Investigator: Louis-Mathieu Stevens, MD, PhD (c)         
Sub-Investigator: Nicolas Noiseux, MD, MSc         
Sub-Investigator: Gilles Soulez, MD         
Sub-Investigator: Carl Chartrand-Lefebvre, MD         
Sub-Investigator: Samer Mansour, MD         
Sub-Investigator: Ignacio Prieto, MD         
Sub-Investigator: Fadi Basile, MD         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: Louis-Mathieu Stevens, MD, PhD (c) Centre Hospitalier de l'Universite de Montreal (CHUM)
  More Information

No publications provided by Centre hospitalier de l'Université de Montréal (CHUM)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Louis-Mathieu Stevens, Principal Investigator, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01585285     History of Changes
Other Study ID Numbers: CHUM-11-233
Study First Received: April 24, 2012
Last Updated: June 28, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Coronary artery bypass grafting
Left internal mammary artery
Composite grafting
Multislice Spiral Computed Tomography Scanner
Graft patency assessment

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014