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ISRCTN
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ISRCTN77486578
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ClinicalTrials.gov identifier
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Public title
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A pilot study of stenting of autologous saphenous vein on early graft remodelling after coronary artery bypass surgery
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Scientific title
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Acronym
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EXTENT-1
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Serial number at source
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PG/96147
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Study hypothesis
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Brief summary:
Bypass grafting using leg veins is a very effective surgical treatment for advanced coronary heart disease, although the initial benefits of the operation tend to be lost over the following years. This is because the vein grafts themselves become blocked like the original coronary arteries. Many attempts have been made to prevent these late failures either by variations in surgical technique or by using drugs, however the problem remains. Based on a British Heart Foundation funded collaboration between basic scientists and cardiac surgeons stretching over the past 10 years, a radically new therapy has been devised. This involves wrapping the vein in a stocking-like material during the bypass operation so that it will be continuously supported during its life as a graft. In experimental studies,this has had a dramatic effect in reducing the thickening of the graft wall. The present project will be the first test of the effectiveness of the new technique in man.
Hypothesis:
Application of a highly porous non-restrictive external stent to autologous saphenous veins at the time of implantation of coronary artery bypass grafts will reduce graft thickening and neointima formation and increase lumen size.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Prevention of saphenous vein graft stenosis by the use of an external stent
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Participants - inclusion criteria
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Patients undergoing coronary artery bypass surgery
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Participants - exclusion criteria
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Re-do surgery, first CABG with an associated procedure, associated valve disease, recent MI (<1 month), poor ejection fraction (<30%), diabetes, previous history of inflammatory disease and unwillingness to participate in follow-up.
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Anticipated start date
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01/03/2005
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Anticipated end date
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30/03/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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40
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Interventions
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1. One group of patients will receive conventional bypass graft surgery with saphenous vein
2. In the second group the saphenous vein will be supported with a polyester made stent
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Primary outcome measure(s)
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Study endpoints: Graft wall thickness and luminal size using intravascular ultrasound (IVUS) at time of operation and at follow-up. Wall and luminal volume will be computed from the 3-D reconstructions and compared to values obtained intraoperatively. Final wall and luminal volumes and the changes in these parameters will be compared in stented and unstented grafts. Angiography will be carried out as a necessary adjunct to intravascular ultrasound at follow-up.
Clinical Outcomes: Adverse clinical events, including death, myocardial infarction, bleeding, infections, need for reoperation, recurrence of
symptoms will be recorded.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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British Heart Foundation (PG/96147)
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Trial website
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Publications
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Contact name
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Prof
Gianni
Angelini
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Address
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Department of Cardiac Surgery
United Bristol Healthcare Trust
Bristol Heart Institute
Bristol Royal Infirmary
Marlborough Street
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City/town
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Bristol
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Zip/Postcode
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BS2 8HW
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Country
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United Kingdom
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Tel
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+44 (0)117 928 3145
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Fax
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+44 (0)117 929 9737
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Email
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G.D.Angelini@bristol.ac.uk
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Sponsor
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British Heart Foundation (UK)
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Address
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14 Fitzhardinge Street
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City/town
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London
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Zip/Postcode
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W1H 6DH
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Country
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United Kingdom
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Tel
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+44 (0)20 7935 0185
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Fax
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+44 (0)20 7486 5820
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Email
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research@bhf.org.uk
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Sponsor website:
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http://www.bhf.org.uk/
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Date applied
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29/10/2001
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Last edited
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21/11/2005
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Date ISRCTN assigned
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29/10/2001
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