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| [ ...Back to search results ] | [ Print-friendly version ] |
| Stentprotected Percutaneous Angioplasty of the Carotid artery versus Endarterectomy |
| ISRCTN | ISRCTN57874028 |
| ClinicalTrials.gov identifier | |
| Public title | Stentprotected Percutaneous Angioplasty of the Carotid artery versus Endarterectomy |
| Scientific title | |
| Acronym | SPACE |
| Serial number at source | N/A |
| Study hypothesis |
To compare carotid endarterectomy (CEA) and carotid stenting in patients with symptomatic >70% carotid artery stenosis.
To prove equivalence in the treatment of symptomatic >70% carotid artery stenosis in: a. Prevalence of ipsilateral stroke (modified Rankin ≥4) or death at 30 days b. Prevalence of ipsilateral stroke or death within 24 months after randomisation c. Restenosis (>70%) according to North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria at 6, 12, 24 months d. Procedural failure: technical or serious adverse events (SAE), subacute occlusion, (re)stenosis of 70% NASCET within 7 days e. Prevalence of any stroke within 30 days and 2 years after randomisation |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Stroke, secondary prevention |
| Participants - inclusion criteria |
a. Symptomatic (Amaurosis fugax, transient ischemic attack [TIA], prolonged reversible ischaemic neurologic deficit [PRIND], complete stroke), Stenosis of the carotid bifurcation or the internal carotid artery (ICA) within 180 days before randomisation
b. Clinical impairment not more than 3 of the modified Rankin scale c. Age at least 50 years d. Negative pregnancy test for women with childbearing potential e. Possibility to participate on the follow-up visits f. Written informed consent g. Stenosis of the carotid bifurcation or the ICA on the clinically symptomatic side with at least 70% according the criteria of the European Carotid Surgery Trial (ECST) or at least 50% after the criteria of the NASCET |
| Participants - exclusion criteria |
a. Intracranial bleeding within the last 90 days before treatment
b. Uncontrolled hypertension c. Proved intracranial vessel malformation (aneurysm or arteriovenous malformation [AVM]) d. Known cardiac cause of thromboembolism e. Concomittant disease that will prevent the patient from attending follow up or known malignancy f. Not correctable coagulation abnormality g. Contraindication against Heparin, acetylsalicylic acid (ASA), Ticlopidine, or Clopidogrel h. Contraindication against contrast medium i. Occlusion of the common carotid artery (CCA) or ICA j. Stenosis by an external compression (e.g. by tumour) k. Stenosis caused by dissection l. Restenosis after surgical or endovascular treatment m. Radiation-induced stenosis n. Fibromuscular dysplasia o. Thrombusformation within the stenosis p. Tandemstenosis if the distal stenosis is more severe than the proximal one q. Planned simultaneous surgical procedures |
| Anticipated start date | 01/03/2001 |
| Anticipated end date | 31/12/2005 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 1900 |
| Interventions | Carotid endarterectomy or Carotid artery stenting |
| Primary outcome measure(s) | Occurrence of an ipsilateral stroke (ischaemic stroke and/or intracerebrale bleeding with symptoms lasting more than 24 hours) or the death of every cause, between randomisation and day 30 |
| Secondary outcome measure(s) |
1. Ipsilateral stroke (ischaemic stroke and/or intracerebral bleeding) or vascular death within the follow-up period of 24 months, beginning with the time of randomisation
2. Restenosis with at least 70% measured by Duplexsonography according to 70%-stenosis following the ECST-criteria or at least a 50%-stenosis after the criteria of the NASCET after 6, 12 and 24 months 3. Procedural technical failure (technically not feasible treatment, serious adverse events [SAE] during and/or by the treatment, occlusion of the vessel or restenosis with at least 70% measured by Duplexsonography according to 70%-stenosis following the ECST-criteria or at least a 50%-stenosis after the criteria of the NASCET on the 6th day ± 1 day and 30th day ± 3 day after treatment) 4. Ipsilateral stroke (ischaemic stroke and/or intracerebral bleeding with an impairment ≥3 on the modified Rankin scale) or death of every cause, between randomisation and day 30 ± 3 after treatment 5. Strokes of every localisation and severity 30 ± 3 days after the intervention 6. Strokes of every localisation and severity within 24 months ± 14 days after the intervention |
| Sources of funding |
Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung) (BMBF)
German Research Foundation ((Deutsche Forschungsgemeinschaft) (DFG) Guidant Boston Scientific Sanofi-Aventis German Neurological Society |
| Trial website | http://www.space.stroke-trial.com/ |
| Publications |
Ringleb PA, Kunze A, Allenberg JR, Hennerici MG, <i>et al.</i> (2004)
The Stent-Supported Percutaneous Angioplasty of the Carotid Artery vs. Endarterectomy Trial. Cerebrovasc Dis 18(1):66-68 <a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15178989&query_hl=2" target="_blank">http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15178989&query_hl=2</a> Ringleb P, Kunze A, Allenberg JR, Hennerici M, <i>et al.</i> (2003) [Evaluation of stent-protected angioplasty for theray of symptomatic stenoses of the carotid artery. SPACE and other randomized trials]. Nervenarzt 74(6):482-8 <a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12799786&query_hl=4" target="_blank">http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12799786&query_hl=4</a> http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=17027729 |
| Contact name | Prof Werner Hacke |
| Address |
Department of Neurology
Im Neuenheimer Feld 400 |
| City/town | Heidelberg |
| Zip/Postcode | 69120 |
| Country | Germany |
| Sponsor | Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung) (BMBF) (Germany) |
| Address | Hannoversche Straße 28-30 |
| City/town | Berlin |
| Zip/Postcode | 10115 |
| Country | Germany |
| Sponsor website: | http://www.bmbf.de |
| Date applied | 15/06/2005 |
| Last edited | 19/10/2006 |
| Date ISRCTN assigned | 02/08/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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