The 2nd European Carotid Surgery Trial

Recruiting

• Conditions: carotid narrowing; atherosclerotic carotid artery stenosis; 10007963

• Registration Number: NL-OMON46858
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

- > 18 years of age
- symptomatic or asymptomatic atherosclerotic carotid stenosis equivalent to at least 50% measured using de NASCET method
- CAR (carotid artery risk) score < 15% 5-year risk
- clinicians are uncertain about which treatment modality is best for the individual patient

Exclusion Criteria

- Modified Rankin score > 2
- previous endarterectomy or stent in the randomised artery
- coronary artery bypass grafting within 3 months prior to randomisation or other major surgery within 6 weeks prior to randomisation
- coronary artery bypass grafting or other major surgery planned within 6 weeks randomisation
- pregnancy
- life expectancy of less than two years due to a pre-existing condition e.g. cancer.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Any stroke at any time, plus non-stroke death occurring within 30 days of<br /><br>revascularisation</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Ipsilateral stroke<br /><br>- myocardial infarction or any hospitalisation for<br /><br>- vascular disease during follow up.<br /><br>- Disabling stroke during follow up.<br /><br>- New cerebral infarction or haemorrhage on post procedural MRI.<br /><br>- Cognitive impairment.<br /><br>- Further treatment procedure.<br /><br>- Adverse events attributed to medical treatment or CEA.<br /><br>- Quality of life and economic measures.</p><br>