Prospective randomised controlled trial of femoropopliteal stenting in patients with critical ischaemia
| ISRCTN | ISRCTN75212451 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75212451 |
| Secondary identifying numbers | N0199119925 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 05/12/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr RB Galland
Scientific
Scientific
Department of Surgery
Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom
| Phone | +44 (0)118 987 7419 |
|---|---|
| abc@email.com |
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 | Prospective randomised controlled trial of femoropopliteal stenting in patients with critical ischaemia |
| Study objectives | In patients with critical ischaemia, does femoropoliteal stenting improve patient outcome over angioplasty? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Critical ischaemia |
| Intervention | Femoropoliteal stenting vs angioplasty |
| Intervention type | Other |
| Primary outcome measure | 1. Patency of superficial femoral and popliteal artery at 6 and 12 months 2. Wound healing. Need for further revascularisation 3. Amputation (level) 4. Morbidity and mortality |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 09/10/2002 |
| Completion date | 31/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 110 |
| Key inclusion criteria | 110 adults - 55 in each arm - if angiogram shows stenosis or occlusion in femoral or popliteal arteries, lesion is amenable to angioplasty and therefore IIS, angioplasty is first line treatment. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 09/10/2002 |
| Date of final enrolment | 31/08/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Berkshire Hospital
Reading
RG1 5AN
United Kingdom
RG1 5AN
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Royal Berkshire and Battle Hospitals NHS Trust (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 |
