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ISRCTN
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ISRCTN78592017
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ClinicalTrials.gov identifier
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Public title
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Stent-protected angioplasty in asymptomatic carotid artery stenosis: SPACE-2
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Scientific title
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Stent-protected angioplasty in asymptomatic carotid artery stenosis: a randomised, controlled, open, multi-centre study
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Acronym
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SPACE-2
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Serial number at source
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N/A
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Study hypothesis
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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
Please note that as of 11/02/2009 this record was updated to include an amended start date. The initial date at the time of registration was:
Initial anticipated start date: 01/07/2007
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Lay summary
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Ethics approval
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Added 11/02/2009: Ethics Committee of the University of Heidelberg gave approval on the 20th October 2008 (ref: S-311/2008)
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Study design
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Randomised, controlled, open, multi-centre study with three parallel groups
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Countries of recruitment
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Austria, Germany, Switzerland
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Disease/condition/study domain
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Asymptomatic moderate to severe stenosis of the extracranial carotid artery
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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Non-atherosclerotic origin of carotid stenosis.
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Anticipated start date
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01/03/2009
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Anticipated end date
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01/07/2015
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Status of trial
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Ongoing |
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Patient information material
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Can be found at: http://www.space-2.de/downloads/SPACE-2%20Patienteninformation.pdf (German only)
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Target number of participants
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3523
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Interventions
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1. Best Medical Treatment (BMT) alone
2. Stent-protected angioplasty and BMT
3. Carotid endarterectomy and BMT
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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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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Sources of funding
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German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
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Trial website
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Publications
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Contact name
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Prof
Werner
Hacke
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Address
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Department of Neurology
University of Heidelberg
Im Neuenheimer Feld 400
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City/town
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Heidelberg
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Zip/Postcode
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69120
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Country
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Germany
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Tel
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+49 (0)6221-568211
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Fax
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+49 (0)6221-565348
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Email
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Werner.Hacke@med.uni-heidelberg.de
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Sponsor
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German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
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Address
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Kennedyallee 40
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City/town
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Bonn
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Zip/Postcode
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53175
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Country
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Germany
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Tel
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+49 (0)228-885-1
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Fax
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+49 (0)228-885-2777
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Email
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postmaster@dfg.de
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Sponsor website:
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http://www.dfg.de
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Date applied
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07/11/2006
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Last edited
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11/02/2009
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Date ISRCTN assigned
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16/07/2007
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