SPACE-2
Stent-protected angioplasty in asymptomatic carotid artery stenosis: SPACE-2
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Purpose:
1. Superiority of stent-protected angioplasty or carotid endarterctomy as compared to best medical treatment with respect to the composite primary endpoint
2. Stent-protected angioplasty is not inferior to carotid endarterectomy with respect to the composite primary endpoint
Interventions:
Best Medical Treatment
up-to-date medical treatment
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Carotid Artery Stenting
Procedure in which the surgeon inserts a slender, metal-mesh tube, called a stent, which expands inside your carotid artery to increase blood flow in areas blocked by plaque.
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Carotid Endarterectomy
An operation during which the surgeon removes the inner lining of your carotid artery if it has become thickened or damaged. Plaque is removed this way.
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Location(s):
Austria, Germany, Switzerland
Year Started:
2008
Design:
Randomised, controlled, open, multi-centre study with three parallel groups
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 stenosis, previous CAS or CEA of target vessel, second higher grade stenosis in same target vessel, severe pre-existing disability (mRS of 3 or greater), contraindications for heparin, clopidogrel, acetylsalicylic acid or contrast agents, high-risk embolic source (artificial valve, atrial fibrillation), life expectancy of less than 2 years.
Patient Involvement:
Patients will be randomized to either (BMT), carotid endarterectomy (CEA), stent-protected angioplasty (CAS);
Randomization is 2:2:1 to the CEA/CAS/BMT-arms, respectively.
Primary Outcome:
Cumulative rate of events consisting of:
1. Any stroke within 30 days of treatment
2. Death from any cause within 30 days
3. Ipsilateral ischaemic stroke within five years
Secondary Outcome:
1. All single components of the primary endpoint clusters
2. Any stroke, vascular death or myocardial infarction within 30 days (five years)
3. Any ischaemic stroke within 30 days (five years)
4. Disabling stroke within 30 days (five years)
5. Technical failure of intervention
6. Rate of re-stenosis (NASCET more than or equal to 50%)
7. Rate of myocardial infarction (30 days)
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Source of Information:
Controlled-Trials.com
Presented at the 2009 International Stroke Conference [February 2009].
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Web Links and Publications:
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This information last updated on: 5/5/2010
Reviewed on: 10/07/2009.
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