Stent-protected angioplasty in asymptomatic carotid artery stenosis vs endarterectomy: two two-arm clinical trials
| ISRCTN | ISRCTN78592017 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78592017 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/11/2006
- Registration date
- 16/07/2007
- Last edited
- 20/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
The aim of this study is to compare up-to-date medical (conservative) treatment (BMT) including lifestyle modification with carotid artery stenting (CAS) and carotid endarterectomy (CEA) in addition to those conservative treatments in the treatment of individuals with asymptomatic atherosclerotic carotid artery stenoses.
Who can participate?
Patients with asymptomatic stenosis of the extracranial carotid artery. Asymptomatic means without stroke or stroke-like symptoms attributable to the target stenosis within the previous 180 days.
What does the study involve?
Patients are allocated to one of the two substudies based on the decision of the including physician and the patient's preference: either CEA (SPACE2a substudy) or CAS (SPACE2b substudy). Patients in the SPACE2a study will be randomly allocated to receive either CEA + BMT or BMT alone, while those in the SPACE2b study will be randomly allocated to receive either CAS + BMT or BMT alone. BMT is defined as the best medical treatment of hypertension, blood glucose and hyperlipidemia according to current guidelines.
What are the possible benefits and risks of participating?
The benefit from every treatment is the proposed reduction of future cerebrovascular and cardiovascular events. Each treatment arm carries specific risks. Risks from the conservative treatment are mainly due to possible side effects of the medication. The most important risk of both CAS and CEA is the risk of periprocedural stroke.
Where is the study run from?
University hospitals of Heidelberg, Kiel and Munich (technical university).
When is the study starting and how long is it expected to run for?
Recruitment of subjects started in October 2009. The overall duration of the trial is expected to be about 9 years.
Who is funding the study?
German Research Council (Deutsche Forschungsgemeinschaft [DFG]), Germany.
Who is the main contact?
Prof. Werner Hacke
Werner.Hacke@med.uni-heidelberg.de
Contact information
Scientific
Department of Neurology
University of Heidelberg
Im Neuenheimer Feld 400
Heidelberg
69120
Germany
| Phone | +49 (0)6221 568211 |
|---|---|
| Werner.Hacke@med.uni-heidelberg.de |
Study information
| Study design | Randomised controlled open multi-centre study with two two-arm clinical trials |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Can be found at: http://www.space-2.de/downloads/SPACE-2%20Patienteninformation.pdf (German only) |
| Scientific title | Stent-protected angioplasty in asymptomatic carotid artery stenosis vs endarterectomy: a randomised, controlled, open, multi-centre study |
| Study acronym | SPACE-2 |
| Study hypothesis | Current hypothesis as of 19/12/2013: Two separate superiority trials of interventions versus best medical treatment (BMT) are designed. The decision for one type of intervention is made (carotid endarterectomy [CEA] = SPACE2a or carotid artery stenting [CAS] = SPACE2b) prior to randomization. In both studies (SPACE2a and SPACE2b) the interventional treatment groups (CEA and CAS) will be compared with best medical treatment (BMT) separately. In addition, data from the CEA and CAS groups will be compared in an explorative manner. Protocol can be found at: http://www.space-2.de/de/service/03/ Previous hypothesis: 1. Superiority of stent-protected angioplasty or carotid endarterectomy (CEA) 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 |
| Ethics approval(s) | 1. Ethics Committee of the University of Heidelberg, 20/10/2008, ref: S-311/2008 2. Ethics Committee of the University of Heidelberg gave approval on change of study design (amendment 25.09.2012) on 04/04/2013 |
| Condition | Asymptomatic moderate to severe stenosis of the extracranial carotid artery |
| Intervention | Current interventions as of 19/12/2013: Patients are allocated to one of the two substudies based on the decision of the including physician and the patient's preference: either CEA (SPACE2a substudy) or CAS (SPACE2b substudy). Patients in the SPACE2a study will be randomly allocated to receive either CEA + BMT or BMT alone, while those in the SPACE2b study will be randomly allocated to receive either CAS + BMT or BMT alone. BMT is defined as optimal medical treatment of hypertension, blood glucose and hyperlipidemia according to current guidelines. Previous interventions: 1. BMT alone 2. Stent-protected angioplasty and BMT 3. Carotid endarterectomy and BMT |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 |
| Secondary outcome measures | 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) |
| Overall study start date | 01/03/2009 |
| Overall study end date | 12/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | 2 x 1636 |
| Total final enrolment | 513 |
| Participant inclusion criteria | 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. |
| Participant exclusion criteria | Non-atherosclerotic origin of carotid stenosis. |
| Recruitment start date | 09/07/2009 |
| Recruitment end date | 12/12/2014 |
Locations
Countries of recruitment
- Austria
- Germany
- Switzerland
Study participating centre
69120
Germany
Sponsor information
Research council
Kennedyallee 40
Bonn
53175
Germany
| Phone | +49 (0)228 885 1 |
|---|---|
| postmaster@dfg.de | |
| Website | http://www.dfg.de |
"ROR" |
https://ror.org/018mejw64 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- German Research Association, German Research Foundation, DFG
- Location
- Germany
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/08/2009 | Yes | No | |
| Results article | results | 01/06/2016 | Yes | No | |
| Results article | results | 15/03/2019 | 04/08/2020 | Yes | No |
| Results article | 01/10/2022 | 20/09/2022 | Yes | No |
Editorial Notes
20/09/2022: Publication reference added.
26/08/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/10/2009 to 09/07/2009.
2. The recruitment end date was changed from 01/07/2020 to 12/12/2014.
3. The overall end date was changed from 01/07/2020 to 12/12/2019.
4. The plain English summary was updated to reflect these changes.
04/08/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
18/04/2016: Publication reference added.
On 07/01/2014 the overall trial end date was changed from 01/07/2015 to 01/07/2020.
On 19/12/2013 the following changes were made to the trial record:
1. The public title was changed from 'Stent-protected angioplasty in asymptomatic carotid artery stenosis: SPACE-2' to 'Stent-protected angioplasty in asymptomatic carotid artery stenosis vs endarterectomy: two two-arm clinical trials'
2. The scientific title was changed from 'Stent-protected angioplasty in asymptomatic carotid artery stenosis: a randomised, controlled, open, multi-centre study' to 'Stent-protected angioplasty in asymptomatic carotid artery stenosis vs endarterectomy: a randomised, controlled, open, multi-centre study'
3. The study design was changed from 'Randomised controlled open multi-centre study with three parallel groups' to 'Randomised controlled open multi-centre study with two two-arm clinical trials'
4. The target number of participants was changed from '3523' to '2 x 1636'
On 11/02/2009 this record was updated to include an amended overall trial start date. The initial date at the time of registration was 01/07/2007.
