Stent-protected Percutaneous Angioplasty of the Carotid artery versus Endarterectomy
| ISRCTN | ISRCTN57874028 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57874028 |
| Secondary identifying numbers | N/A |
- 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
Not provided at time of registration
Contact information
Prof Werner Hacke
Scientific
Scientific
Department of Neurology
Im Neuenheimer Feld 400
Heidelberg
69120
Germany
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Stent-protected Percutaneous Angioplasty of the Carotid artery versus Endarterectomy |
| Study 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(s) | Not provided at time of registration |
| Condition | Stroke, secondary prevention |
| Intervention | Carotid endarterectomy or Carotid artery stenting |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/03/2001 |
| Overall study end date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1900 |
| 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 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
Study participating centre
Department of Neurology
Heidelberg
69120
Germany
69120
Germany
Sponsor information
Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung) (BMBF) (Germany)
Government
Government
Hannoversche Straße 28-30
Berlin
10115
Germany
| Website | http://www.bmbf.de |
|---|---|
"ROR" |
https://ror.org/04pz7b180 |
Funders
Funder type
Industry
Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung) (BMBF)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
German Research Foundation ((Deutsche Forschungsgemeinschaft) (DFG)
No information available
Guidant
No information available
Boston Scientific
No information available
Sanofi-Aventis
No information available
German Neurological Society
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
06/08/2019: Publication reference added.
26/10/2018: Publication reference added.
