A pilot study of stenting of autologous saphenous vein on early graft remodelling after coronary artery bypass surgery
| ISRCTN | ISRCTN77486578 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77486578 |
| Secondary identifying numbers | PG/96147 |
- Submission date
- 29/10/2001
- Registration date
- 29/10/2001
- Last edited
- 24/07/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Gianni Angelini
Scientific
Scientific
Department of Cardiac Surgery
United Bristol Healthcare Trust
Bristol Heart Institute
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
| Phone | +44 (0)117 928 3145 |
|---|---|
| G.D.Angelini@bristol.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | EXTENT-1 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/2005 |
| Completion date | 30/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 40 |
| Key inclusion criteria | Patients undergoing coronary artery bypass surgery |
| Key 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 |
| Date of first enrolment | 01/03/2005 |
| Date of final enrolment | 30/03/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Cardiac Surgery
Bristol
BS2 8HW
United Kingdom
BS2 8HW
United Kingdom
Sponsor information
British Heart Foundation (UK)
Charity
Charity
14 Fitzhardinge Street
London
W1H 6DH
United Kingdom
| Phone | +44 (0)20 7935 0185 |
|---|---|
| research@bhf.org.uk | |
| Website | http://www.bhf.org.uk/ |
"ROR" |
https://ror.org/02wdwnk04 |
Funders
Funder type
Charity
British Heart Foundation (UK) (PG/96147)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2007 | Yes | No |
