Stent-protected angioplasty in asymptomatic carotid artery stenosis vs endarterectomy: two two-arm clinical trials
Not Applicable
Completed
- Conditions
- Asymptomatic moderate to severe stenosis of the extracranial carotid arteryCirculatory SystemCerebrovascular diseases
- Registration Number
- ISRCTN78592017
- Lead Sponsor
- German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
- Brief Summary
2009 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/19689759 protocol 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27085660 results 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/30873912/ results (added 04/08/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36115360/ (added 20/09/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 513
Inclusion Criteria
Sonographic identification of a more than or equal to 50% stenosis (North American Symptomatic Carotid Endarterectomy Trial [NASCET] criteria) of the extracranial carotid artery in a patient (both genders, age limit 85 years) without symptoms attributable to the target stenosis within the previous 180 days.
Exclusion Criteria
Non-atherosclerotic origin of carotid stenosis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Cumulative rate of events consisting of:<br> 1. Any stroke within 30 days of treatment<br> 2. Death from any cause within 30 days<br> 3. Ipsilateral ischaemic stroke within five years<br>
- Secondary Outcome Measures
Name Time Method <br> 1. All single components of the primary endpoint clusters<br> 2. Any stroke, vascular death or myocardial infarction within 30 days (five years)<br> 3. Any ischaemic stroke within 30 days (five years)<br> 4. Disabling stroke within 30 days (five years)<br> 5. Technical failure of intervention<br> 6. Rate of re-stenosis (NASCET more than or equal to 50%)<br> 7. Rate of myocardial infarction (30 days)<br>