Condition category
Surgery
Date applied
29/10/2001
Date assigned
29/10/2001
Last edited
24/07/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.bhf.org.uk/

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

Results - basic reporting

Publication summary

1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17662798

Publication citations

  1. 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.

Additional files

Editorial Notes