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

N/A

Waitlist Available

Led By Alison Halliday

Research Sponsored by University of Oxford

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

No Placebo-Only Group

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

Who is the study for?

This trial is for patients with asymptomatic carotid artery narrowing who haven't had symptoms or previous procedures on the affected artery. They must be on medical treatment like statins, have completed any heart procedures, and be able to attend follow-ups. Both surgery (CEA) and stenting (CAS) should be possible options without a clear preference for either.

What is being tested?

The study compares two treatments for carotid artery narrowing: Carotid Endarterectomy (CEA), which is surgery to remove plaque from inside the carotid artery, and Carotid Artery Stenting (CAS), where a mesh tube is inserted to widen the narrowed part of the artery. It assesses immediate risks and long-term benefits.

What are the potential side effects?

Possible side effects include stroke, heart attack, bruising or bleeding at the intervention site, reactions to anesthesia or contrast dye used in stenting procedure, nerve injury causing issues with swallowing or speaking, restenosis (re-narrowing of the artery), and blood clots.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

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.