A multicentre prospective randomised trial comparing angioplasty versus stenting for the management of iliac occlusions
| ISRCTN | ISRCTN48145465 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48145465 |
| Secondary identifying numbers | 940028 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 12/07/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof P Gaines
Scientific
Scientific
Sheffield Vascular Institute
Northern General Hospital NHS Trust
Herries Road
Sheffield
S5 7AU
United Kingdom
| Phone | +44 (0)114 2714345 |
|---|---|
| p.a.gaines@sheffield.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 objectives | Do iliac stents improve the safety and efficacy of treating iliac occlusions compared to angioplasty? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular diseases: Peripheral arterial disease |
| Intervention | 1. Iliac stents 2. Angioplasty |
| Intervention type | Other |
| Primary outcome measure | 1. Primary success - residual gradient <10 mm mercury 2. Cost of initial treatment 3. Cost of hospital stays 4. Cost of re-intervention 5. Statistical analysis |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/1994 |
| Completion date | 01/02/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 140 patients, 40 patients over 1 year in Sheffield |
| Key inclusion criteria | 1. Males and females above 18 years 2. Iliac artery/occlusion 8 cm or less. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/1994 |
| Date of final enrolment | 01/02/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Sheffield Vascular Institute
Sheffield
S5 7AU
United Kingdom
S5 7AU
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Trent (UK)
No information available
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 | 01/08/2013 | Yes | No |
