Contact information
Type
Scientific
Primary contact
Prof P Gaines
ORCID ID
Contact details
Sheffield Vascular Institute
Northern General Hospital NHS Trust
Herries Road
Sheffield
S5 7AU
United Kingdom
+44 (0)114 2714345
p.a.gaines@sheffield.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
940028
Study information
Scientific title
Acronym
Study hypothesis
Do iliac stents improve the safety and efficacy of treating iliac occlusions compared to angioplasty?
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
Cardiovascular diseases: Peripheral arterial disease
Intervention
1. Iliac stents
2. Angioplasty
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/09/1994
Overall trial end date
01/02/2002
Reason abandoned
Eligibility
Participant inclusion criteria
1. Males and females above 18 years
2. Iliac artery/occlusion 8 cm or less.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
140 patients, 40 patients over 1 year in Sheffield
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/1994
Recruitment end date
01/02/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Sheffield Vascular Institute
Sheffield
S5 7AU
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Trent (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23842828
Publication citations
-
Results
Goode SD, Cleveland TJ, Gaines PA, , Randomized clinical trial of stents versus angioplasty for the treatment of iliac artery occlusions (STAG trial)., Br J Surg, 2013, 100, 9, 1148-1153, doi: 10.1002/bjs.9197.