Stent-protected Percutaneous Angioplasty of the Carotid artery versus Endarterectomy

ISRCTN	ISRCTN57874028
DOI	https://doi.org/10.1186/ISRCTN57874028
Protocol serial number	N/A
Sponsor	Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung) (BMBF) (Germany)
Funders	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

Submission date: 15/06/2005
Registration date: 02/08/2005
Last edited: 06/08/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Werner Hacke
Scientific

Department of Neurology
Im Neuenheimer Feld 400
Heidelberg
69120
Germany

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Stent-protected Percutaneous Angioplasty of the Carotid artery versus Endarterectomy
Study acronym	SPACE
Study objectives	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
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Stroke, secondary prevention
Intervention	Carotid endarterectomy or Carotid artery stenting
Intervention type	Other
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
Key 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
Completion date	31/12/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	1900
Key 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
Key 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
Date of first enrolment	01/03/2001
Date of final enrolment	31/12/2005

Locations

Countries of recruitment

Germany

Study participating centre

Department of Neurology

Heidelberg
69120
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2004		Yes	No
Results article	results	01/03/2013		Yes	No
Results article	results	01/11/2018		Yes	No
Results article	results	01/08/2019	06/08/2019	Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

06/08/2019: Publication reference added.
26/10/2018: Publication reference added.