Contact information
Type
Scientific
Primary contact
Mr RB Galland
ORCID ID
Contact details
Department of Surgery
Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom
+44 (0)118 987 7419
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0199119925
Study information
Scientific title
Prospective randomised controlled trial of femoropopliteal stenting in patients with critical ischaemia
Acronym
Study hypothesis
In patients with critical ischaemia, does femoropoliteal stenting improve patient outcome over 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: Critical ischaemia
Intervention
Femoropoliteal stenting vs angioplasty
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
09/10/2002
Overall trial end date
31/08/2004
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
110
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
09/10/2002
Recruitment end date
31/08/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Berkshire Hospital
Reading
RG1 5AN
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Royal Berkshire and Battle Hospitals NHS Trust (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