Status:
ACTIVE_NOT_RECRUITING
Carotid Endarterectomy Versus Carotid Artery Stenting in Asymptomatic Patients
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
NHS Health Technology Assessment Programme
BUPA Foundation
Conditions:
Carotid Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The trial randomise patients with asymptomatic carotid artery narrowing in whom prompt physical intervention is thought to be needed, but there there is still substantial uncertainty shared by patient...
Eligibility Criteria
Inclusion
- Carotid artery stenosis detectable by duplex ultrasound, with no ipsilateral carotid territory symptoms(or none for some months) and no previous procedure done on it, which might well need procedural treatment now with CEA or CAS.
- Already started any appropriate medical treatment (eg, statin, aspirin etc), and already recovered from any necessary coronary procedures (eg, CABG)
- Patient seems fit and willing for follow-up in person (at 1 month) and by annual letter (for at least 5 years)
- Investigations show that both procedures (CEA and CAS) appear to be practicable and appropriate
- Some type of angiography (eg, MRA or CTA) has already been done that has shown that CEA and CAS would both be anatomically practicable.
- Doctor and patient both substantially uncertain about whether to treat with CEA or CAS, and the doctor sees no clear indication/contra-indication for either procedure
Exclusion
- Small likelihood of worthwhile benefit (eg, very low risk of stroke because stenosis is very minor, or major co-morbidity or life-threatening disease, such as advanced cancer)
- Unsuitable for one or other procedure (eg, stenosis at carotid siphon that is inaccessible for CEA, or complex vasculature below the stenosis that would hinder CAS, or patient unfit for major surgery)
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
3638 Patients enrolled
Trial Details
Trial ID
NCT00883402
Start Date
January 1 2008
End Date
December 1 2025
Last Update
December 9 2024
Active Locations (125)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Toledo Medical Centre
Toledo, Ohio, United States, 43614
2
Medical University of Innsbruck
Innsbruck, Austria
3
University Hospital Antwerp
Antwerp, Belgium
4
University St Lucas
Brussels, Belgium