Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
07/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.cavatas.com

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes