Condition category
Circulatory System
Date applied
15/06/2005
Date assigned
02/08/2005
Last edited
07/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.space.stroke-trial.com/

Contact information

Type

Scientific

Primary contact

Prof Werner Hacke

ORCID ID

Contact details

Department of Neurology
Im Neuenheimer Feld 400
Heidelberg
69120
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

SPACE

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

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Stroke, secondary prevention

Intervention

Carotid endarterectomy or Carotid artery stenting

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 measures

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

Overall trial start date

01/03/2001

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1900

Participant 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

Recruitment start date

01/03/2001

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Neurology
Heidelberg
69120
Germany

Sponsor information

Organisation

Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung) (BMBF) (Germany)

Sponsor details

Hannoversche Straße 28-30
Berlin
10115
Germany

Sponsor type

Government

Website

http://www.bmbf.de

Funders

Funder type

Industry

Funder name

Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung) (BMBF)

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

Funder name

German Research Foundation ((Deutsche Forschungsgemeinschaft) (DFG)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Guidant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Boston Scientific

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Sanofi-Aventis

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

German Neurological Society

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15178989
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23237679

Publication citations

  1. Results

    Ringleb PA, Kunze A, Allenberg JR, Hennerici MG, Jansen O, Maurer PC, Zeumer H, Hacke W, , The Stent-Supported Percutaneous Angioplasty of the Carotid Artery vs. Endarterectomy Trial., Cerebrovasc. Dis., 2004, 18, 1, 66-68, doi: 10.1159/000078752.

  2. Results

    Rantner B, Goebel G, Bonati LH, Ringleb PA, Mas JL, Fraedrich G, , The risk of carotid artery stenting compared with carotid endarterectomy is greatest in patients treated within 7 days of symptoms., J. Vasc. Surg., 2013, 57, 3, 619-626.e2; discussion 625-6, doi: 10.1016/j.jvs.2012.08.107.

Additional files

Editorial Notes