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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by University of Oxford
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883402

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 Locations
Sponsors 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
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014