Contact information
Type
Scientific
Primary contact
Prof Martin M Brown
ORCID ID
Contact details
Department of Clinical Neurology
Institute of Neurology
Queen Square
London
WC1N 3BG
United Kingdom
+44 (0)20 7829 8753
m.brown@ion.ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MC1
Study information
Scientific title
Acronym
CAVATAS Study
Study hypothesis
Atherosclerosis of the carotid and vertebral arteries in the neck is an important cause of stroke and transient ischaemic attack (TIA). Previous randomised clinical trials have demonstrated that the risks of stroke are significantly reduced by carotid surgery in suitable patients with recent symptoms and severe carotid stenosis. However, surgery has the disadvantage of an incision in the neck which may lead to cranial or superficial nerve injury and wound complications. There is also a significant risk of a stroke caused by the operation and a small risk of myocardial infarction. Carotid surgery is often performed under general anaesthesia, adding further to the potential for complications. Treatment of carotid stenosis by new endovascular techniques using balloon dilation (angioplasty) or stenting avoids a surgical incision and uses only local anaesthetic, but the risks and benefits of endovascular treatment were uncertain. We therefore compared endovascular treatment with conventional treatment in a multicentre international randomised trial.
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
Patient information can be found at: http://www.ion.ucl.ac.uk/cavatas_icss/downloads/Infosheet.pdf
Condition
Cardiovascular diseases: Cerebrovascular disease
Intervention
561 patients were entered in three arms of the trial between 1992 and July 1997. Patients with carotid stenosis suitable for surgery (n=504) were randomised between endovascular treatment and carotid surgery. Patients with carotid stenosis unsuitable for surgery (n=40) and patients with vertebral artery stenosis (n=17) were separately randomised between endovascular treatment and medical care alone. The data from these last 2 groups has not yet been published. The main analysis was restricted to the 504 patients with carotid stenosis randomised between endovascular treatment (n=251) or surgery (n=253). Stents were used in 55 (22%) randomised to endovascular treatment; the remainder were treated by balloon angioplasty alone. Patients were followed up by an independent neurologist.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Survival free of disabling stroke
Secondary outcome measures
Any stroke or death within 30 days of treatment, myocardial infarction within 30 days of treatment, treatment-related cranial nerve palsy or haematoma requiring reoperation or prolonging hospital stay. Stenosis (>70%) and occlusion on ultrasound follow-up. Stroke during follow-up. Further treatment procedure. Quality of life and economic measures.
Overall trial start date
01/01/1992
Overall trial end date
31/07/1997
Reason abandoned
Eligibility
Participant inclusion criteria
For inclusion in the study patients had to have stenosis of the common carotid artery, carotid bifurcation, internal carotid artery or extracranial vertebral artery that investigators considered suitable for endovascular treatment.
Patients eligible for surgery and patients ineligible for surgery were studied and randomised as two separate groups.
Investigators included patients only if the best treatment was unclear i.e. patients were randomly assigned only if they and their carotid or vertebral stenosis were equally suitable for both endovascular treatment and the alternative treatment (surgery or best medical care).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
561
Participant exclusion criteria
Exclusion criteria included patients unable or unwilling to undergo one of the alternative treatment strategies, or who were unable to give informed consent, or if they had a disabling stroke with no useful recovery of function within the region supplied by the treatable artery. Patients were not eligible for the study if angiography showed thrombus in the affected artery, severe intracranial stenosis beyond the skull base, or a stenosis unsuitable for endovascular treatment e.g. because of tortuous vascular anatomy. However, patients did not need to have catheter angiography if a reliable non-invasive investigation had confirmed stenosis. Patients were not excluded if contraindications were noted after random assignment. There was no age limit.
Recruitment start date
01/01/1992
Recruitment end date
31/07/1997
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Clinical Neurology
London
WC1N 3BG
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Cardiovascular Disease and Stroke National Research and Development Programme
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
http://www.thelancet.com/journal/vol357/iss9270/full/llan.357.9270.original_research.16458.1