Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
12/07/2013
Prospective/Retrospective
Retrospectively 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 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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes