Carotid Endarterectomy Versus Carotid Artery Stenting in Asymptomatic Patients (ACST-2)
This study is currently recruiting participants.
Verified June 2012 by University of Oxford
Sponsor:
University of Oxford
Collaborators:
NHS Health Technology Assessment Programme
BUPA Foundation
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT00883402
First received: April 15, 2009
Last updated: June 19, 2012
Last verified: June 2012
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Purpose
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 and doctor about whether surgery or stenting is the more appropriate choice.
The study is looking at immediate risks (within one month)and at long term benefits
| Condition | Intervention |
|---|---|
|
Carotid Stenosis |
Procedure: CEA, CAS |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Asymptomatic Carotid Surgery Trial-2 (ACST-2): an International Randomised Trial to Compare Carotid Endarterectomy With Carotid Artery Stenting to Prevent Stroke |
Further study details as provided by University of Oxford:
Primary Outcome Measures:
- To compare peri-procedural risks (MI, stroke and death) within the first month after the allocated CEA or CAS and long-term (up to 5 or more years) prevention of stroke, particularly disabling or fatal stroke, in subsequent years. [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To identify types of patients to be identified in which one or other procedure is clearly preferable as well as economic evaluation; procedural costs and stroke-related healthcare costs and quality of life. [ Time Frame: 10 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 5000 |
| Study Start Date: | January 2008 |
| Estimated Primary Completion Date: | January 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: CEA
Carotid endarterectomy
|
Procedure: CEA, CAS
Carotid Artery Stenting (CAS) Carotid endarterectomy (CEA)
|
|
Active Comparator: CAS
Carotid Artery Stenting
|
Procedure: CEA, CAS
Carotid Artery Stenting (CAS) Carotid endarterectomy (CEA)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883402
Show 34 Study Locations
Contacts
| Contact: Alison Halliday | + 44 1865 221 345 | acst@nds.ox.ac.uk |
| Contact: Carol Wallis | + 44 1865 221 345 | acst@nds.ox.ac.uk |
Show 34 Study LocationsSponsors and Collaborators
University of Oxford
NHS Health Technology Assessment Programme
BUPA Foundation
Investigators
| Principal Investigator: | Alison Halliday | University of Oxford |
More Information
Additional Information:
Publications:
| Responsible Party: | University of Oxford |
| ClinicalTrials.gov Identifier: | NCT00883402 History of Changes |
| Other Study ID Numbers: | ACST-2 |
| Study First Received: | April 15, 2009 |
| Last Updated: | June 19, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by University of Oxford:
|
Carotid stenosis CEA CAS Stenting |
Additional relevant MeSH terms:
|
Carotid Stenosis Constriction, Pathologic Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 19, 2013