A multicentre prospective randomised trial comparing angioplasty versus stenting for the management of iliac occlusions

ISRCTN	ISRCTN48145465
DOI	https://doi.org/10.1186/ISRCTN48145465
Protocol serial number	940028
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Trent (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof P Gaines
Scientific

Sheffield Vascular Institute
Northern General Hospital NHS Trust
Herries Road
Sheffield
S5 7AU
United Kingdom

Phone	+44 (0)114 2714345
Email	p.a.gaines@sheffield.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/02/2002

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	140
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

Sheffield Vascular Institute

Sheffield
S5 7AU
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2013		Yes	No