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Carotid Endarterectomy Versus Carotid Artery Stenting in Asymptomatic Patients (ACST-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00883402
Recruitment Status : Unknown
Verified April 2019 by University of Oxford.
Recruitment status was:  Recruiting
First Posted : April 17, 2009
Last Update Posted : March 24, 2020
Sponsor:
Collaborators:
NHS Health Technology Assessment Programme
BUPA Foundation
Information provided by (Responsible Party):
University of Oxford

Study Description
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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 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 or disease Intervention/treatment Phase
Carotid Stenosis Procedure: CEA, CAS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2008
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883402


Contacts
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Contact: Alison Halliday + 44 1865 617975 acst@nds.ox.ac.uk
Contact: Richard Bulbulia +44 1865 743891 acst@nds.ox.ac.uk

Locations
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Sponsors and Collaborators
University of Oxford
NHS Health Technology Assessment Programme
BUPA Foundation
Investigators
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Principal Investigator: Alison Halliday University of Oxford
More Information
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Additional Information:

Publications:

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT00883402    
Other Study ID Numbers: ACST-2
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
Carotid stenosis
CEA
CAS
Stenting
Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases