Contact information
Type
Scientific
Primary contact
Prof Gianni Angelini
ORCID ID
Contact details
Department of Cardiac Surgery
United Bristol Healthcare Trust
Bristol Heart Institute
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 928 3145
G.D.Angelini@bristol.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PG/96147
Study information
Scientific title
Acronym
EXTENT-1
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Prevention of saphenous vein graft stenosis by the use of an external stent
Intervention
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
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
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.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/2005
Overall trial end date
30/03/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients undergoing coronary artery bypass surgery
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
40
Participant exclusion criteria
1. Re-do surgery
2. First CABG with an associated procedure
3. Associated valve disease
4. Recent MI (<1 month)
5. Poor ejection fraction (<30%)
6. Diabetes
7. Previous history of inflammatory disease
8. Unwillingness to participate in follow-up
Recruitment start date
01/03/2005
Recruitment end date
30/03/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Cardiac Surgery
Bristol
BS2 8HW
United Kingdom
Sponsor information
Organisation
British Heart Foundation (UK)
Sponsor details
14 Fitzhardinge Street
London
W1H 6DH
United Kingdom
+44 (0)20 7935 0185
research@bhf.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation (UK) (PG/96147)
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17662798
Publication citations
-
Results
Murphy GJ, Newby AC, Jeremy JY, Baumbach A, Angelini GD, A randomized trial of an external Dacron sheath for the prevention of vein graft disease: the Extent study., J. Thorac. Cardiovasc. Surg., 2007, 134, 2, 504-505, doi: 10.1016/j.jtcvs.2007.01.092.