Carotid artery stenting during endovascular treatment of acute ischemic stroke
| ISRCTN | ISRCTN14956654 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14956654 |
| ClinicalTrials.gov number | Nil Known |
- Submission date
- 05/12/2022
- Registration date
- 18/01/2023
- Last edited
- 15/07/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
A stroke is a serious life-threatening medical condition that happens when the blood supply to part of the brain is cut off. Approximately 1 in 5 patients suffering stroke have a narrowed carotid artery. It is not yet known if early treatment to insert a tube (stent) into the narrowed artery to hold it open and prevent future stroke is worth the difficulties associated with such treatment.
Who can participate?
Patients with acute ischemic stroke with a CT-angiography-proven intracranial LVO in the anterior circulation (ICA, A1, M1 or M2) as well as an ipsilateral cervical carotid artery tandem lesion of presumed atherosclerotic origin with a stenosis >50% or an ipsilateral acute proximal internal carotid artery occlusion who are treated with EVT according to the guidelines.
What does the study involve?
Patients will be randomly allocated to receive either a carotid artery stent immediately after suffering a stroke, or to treatment as usual.
What are the possible benefits and risks of participating?
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All patients are being treated with EVT according to the local guidelines. The patients allocated to the intervention group will undergo CAS during EVT, which carries a risk of cerebral hyperperfusion syndrome and subsequent intracerebral hemorrhage. The potential benefits of immediate CAS during thrombectomy include: an improvement of cerebral blood flow during and after EVT. A second benefit is a lower risk of recurrent stroke in the first 14 days compared to the deferred treatment strategy. A third benefit of immediate CAS is that the patient does not need a second invasive treatment (carotid revascularization surgery (CEA or CAS) during the rehabilitation period which again carries some risk of complications. At last, the immediate CAS approach is likely to reduce health care costs.
Where is the study run from?
The study will be coordinated by the University Medical Center Groningen in the Netherlands and by the University Hospital Leuven in Belgium. 26 centres (9 in Belgium and 17 in the Netherlands) will participate.
When is the study starting and how long is it expected to run for?
November 2022 to November 2026
Who is funding the study?
The study is part of the COllaboration of New TReatments of Acute STroke (CONTRAST) consortium (https://www.contrast-consortium.nl).
The study is funded by the BeNeFIT funding members (ZonMw/KCE) (the Netherlands)
Who is the main contact?
Dr M. Uyttenboogaart, m.uyttenboogaart@umcg.nl
Contact information
Principal Investigator
UMC Groningen
Hanzeplein 1
Groningen
9713 GZ
Netherlands
 ORCID ID |
0000-0002-6934-4456 |
|---|---|
| Phone | +31 50 3612400 |
| m.uyttenboogaart@umcg.nl |
Principal Investigator
UZ Leuven
Herestraat 49
Leuven
3000
Belgium
| ORCID ID |
0000-0003-3374-1502 |
|---|---|
| Phone | +32 16 34 42 80 |
| robin.lemmens@uzleuven.be |
Study information
| Study design | Randomized multicenter clinical trial with a PROBE design and a non-inferiority design. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment, Safety, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Carotid Artery Stenting during Endovascular treatment of acute ischemic Stroke: a randomized multicenter clinical trial in patients with acute ischemic stroke and carotid artery stenosis undergoing endovascular treatment |
| Study acronym | CASES |
| Study hypothesis | Immediate carotid artery stenting is non-inferior compared to a deferred treatment of carotid artery stenosis/occlusion in patients with large vessel occlusion in the anterior circulation treated with endovascular thrombectomy. |
| Ethics approval(s) |
1. Approved 19/06/2023, Medische Ethische toetsingscommissie Erasmus MC Rotterdam (Postbus 20403000, Rotterdam, CA, Netherlands; +31 10-70 34428 ; metc@erasmusmc.nl), ref: NL79046.078.23 (MEC-2023-0131) 2. Approved 19/06/2023, Ethics Committee Research UZ/KU Leuven (UZ Leuven, Herestraat 49, Leuven, B 3000, Belgium; +32 16 34 86 00; ec@uzleuven.be), ref: B3222022001112. (S65073) |
| Condition | Acute ischemic stroke in patients with large vessel occlusion in the anterior circulation and a concommitant high grade ipsilateral carotid artery stenosis or occlusion of presumed atherosclerotic origin.. |
| Intervention | Patients with an ipsilateral high grade carotid artery stenosis or occlusion of presumed atherosclerotic origin and an proximal intracranial large vessel occlusion in the anterior circulation will be randomized using a web-based randomization tool to immediate carotid artery stenting or deferred treatment strategy of carotid artery stenosis. In the intervention group, the cervical carotid artery lesion will be treated with a stent during the EVT (just before or directly after intracranial thrombus removal), the control group will be treated according to the national guidelines with carotid endarterectomy of carotid artery stenting (for patients with non-disabling stroke) or medical management alone (for patients with severe disabling stroke). Follow up at 90 days. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Stroke-related disability measured using the Modified Rankin Scale (mRS) Score at 90 days after stroke onset.The mRS score will be assessed by stroke research personnel by telephone interview, blinded for the treatment allocation |
| Secondary outcome measures | 1. NIHSS score at 24 hours and day 5-7, or at discharge (Medical examination) 2. Adequate recanalization after EVT (TICI 2b or higher) (Review of performed imaging) 3. Final infarct volume on brain CT at 24 hours (Review of performed imaging) 4. Arterial occlusive lesion (AOL) score on CTA at 24 hours (Review of performed imaging) 5. Any stroke within 90 days (Obtained from medical records) 6. Recurrent ipsilateral TIA/ischemic stroke within 90 days 7. Carotid artery re-occlusion at 24 hours and 90 days (Review of performed imaging) 8. Mortality at 90 days (Obtained from medical records) 9. Quality of life (EQ5D-5L) questionnaire at 90 days |
| Overall study start date | 15/11/2022 |
| Overall study end date | 15/11/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 600 |
| Participant inclusion criteria | 1. Acute ischemic stroke due to proximal intracranial occlusion in the anterior circulation (intracranial ICA, M1, proximal M2) on the CT angiography 2. Stenosis >50% according to the NASCET criteria16 or initial occlusion of the ipsilateral cervical carotid artery of presumed atherosclerotic origin on baseline CT angiography 3. Eligible for EVT according to the guidelines: EVT within 6 hours of onset or EVT between 6-24 hours after onset based on perfusion CT imaging selection (conform current guidelines) 4. Baseline National Institute of Health Stroke Scale (NIHSS) score ≥2 5. Age >18 years 6. Written informed consent (deferred consent) |
| Participant exclusion criteria | 1. Any intracranial hemorrhage 2. Cervical carotid artery stenosis or occlusion with other causes than presumed atherosclerosis (e.g. carotid artery dissection, floating thrombus, carotid web) 3. Any exclusion criterion for EVT according to the guidelines 4. Pre stroke disability (defined as a modified Rankin Scale score >2) 5. Recent gastro-intestinal or urinary tract hemorrhage (<6 weeks) 6. Recent severe head trauma (<6 weeks) 7. Recent infarction on baseline brain CT in the same vascular territory (<6 weeks) 8. Known allergy to aspirin and/or clopidogrel 9. Pregnancy |
| Recruitment start date | 19/06/2023 |
| Recruitment end date | 01/05/2026 |
Locations
Countries of recruitment
- Belgium
- Netherlands
Study participating centres
Groningen
9713 GZ
Netherlands
Leuven
3000
Belgium
Amsterdam
1105 AZ
Netherlands
Rotterdam
3015 GD
Netherlands
Leiden
2333 ZA
Netherlands
Maastricht
6229 HX
Netherlands
Utrecht
3584 CX
Netherlands
Zwolle
8025 AB
Netherlands
Den Haag
2512 VA
Netherlands
Den Haag
2545 AA
Netherlands
Arnhem
6815 AD
Netherlands
Eindhoven
5623 EJ
Netherlands
Breda
4818 CK
Netherlands
Enschede
7512 KZ
Netherlands
Alkmaar
1815 JD
Netherlands
Dordrecht
3318 AT
Netherlands
Nijmegen
6525 GA
Netherlands
Nieuwegein
3435 CM
Netherlands
Brugge
8000
Belgium
Bruxelles
1070
Belgium
Gent
9000
Belgium
Charleroi
6042
Belgium
Jette
1090
Belgium
Kortrijk
8500
Belgium
Liège
4000
Belgium
Edegem
2650
Belgium
Tilburg
5022 GC
Netherlands
Brussel
1200
Belgium
Sponsor information
Hospital/treatment centre
Hanzeplein 1
Groningen
9713 GZ
Netherlands
| Phone | +31 50 3616161 |
|---|---|
| dlrvb@umcg.nl | |
| Website | http://www.umcg.nl/EN |
"ROR" |
https://ror.org/03cv38k47 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 15/11/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request after central review by the "Data Access Writing Committee" from the CONTRAST consortium. |
Editorial Notes
15/07/2024: The public title was changed from 'Using a tube (stent) inserted into a blood vessel in the neck (carotid artery) during treatment of stroke' to 'Carotid artery stenting during endovascular treatment of acute ischemic stroke'.
09/07/2024: Amsterdam University Medical Center, Erasmus Medical Center Rotterdam, Leiden University Medical Center, Maastricht University Medical Center, Utrecht University Medical Center, Isala Zwolle, Haaglanden Medisch Centrum, Haga Medisch Centrum, Rijnstate ziekenhuis, Catharina Ziekenhuis Eindhoven, Amphia Ziekenhuis, Medisch Spectrum Twente, Noordwest Ziekenhuisgroep, Albert Schweitzer ziekenhuis, Radboud University Medical Center, Sint Antonius Ziekenhuis, AZ Sint Jan, Hopital Erasme, Universitair Ziekenhuis Gent, Civil Hospital Marie Curie, UZ Brussel, AZ Groeninge, CHU Liège, Universitair Ziekenhuis Antwerpen, Elisabeth Tweesteden Ziekenhuis and UCL Saint-Luc were added to the study particpating centres.
19/06/2023: The following changes were made to the trial record:
1. The study types 'safety' and 'efficacy' were added.
2. The study website was added.
3. The recruitment start date was changed from 15/06/2023 to 19/06/2023.
4. The ethics approval was added.
22/05/2023: The recruitment start date was changed from 01/05/2023 to 15/06/2023.
05/12/2022: Trial's existence confirmed by ZonMw
