Stroke, AcutePhase 3CASESNCT06511089
Carotid Artery Stenting During Endovascular Treatment of Acute Stroke
A Phase 3 study testing carotid artery stenting during EVT and no carotid artery stenting during EVT in people with Stroke, Acute and Stroke, Ischemic, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Rationale: Approximately 20% of the patients with acute ischemic stroke due to an intracranial large vessel occlusion (LVO) has a high-grade stenosis in the ipsilateral cervical carotid artery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Stroke, Ischemic, Carotid Stenosis
- What is being tested?
- carotid artery stenting during EVT and no carotid artery stenting during EVT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Nov 2022to 15 Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute ischemic stroke due to proximal intracranial occlusion in the anterior circulation (intracranial ICA, M1, proximal M2) on the CT angiography
- Stenosis >50% according to the NASCET criteria16 or initial occlusion of the ipsilateral cervical carotid artery of presumed atherosclerotic origin on baseline CT angiography
- 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)
- Baseline National Institute of Health Stroke Scale (NIHSS) score ≥2
- Age >18 years
- Written informed consent (deferred consent)
Who cannot join
- Any intracranial hemorrhage
- Cervical carotid artery stenosis or occlusion with other causes than presumed atherosclerosis (e.g. carotid artery dissection, floating thrombus, carotid web)
- Any exclusion criterion for EVT according to the guidelines
- Pre stroke disability (defined as a modified Rankin Scale score >2)
- Recent gastro-intestinal or urinary tract hemorrhage (<6 weeks)
- Recent severe head trauma (<6 weeks)
Show all 9Show fewer
- Recent infarction on baseline brain CT in the same vascular territory (<6 weeks)
- Known allergy to aspirin and/or clopidogrel
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713 GZ
Maarten Uyttenboogaart, MD PhD, m.uyttenboogaart@umcg.nl
About this study
Official 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
Rationale: Approximately 20% of the patients with acute ischemic stroke due to an intracranial large vessel occlusion (LVO) has a high-grade stenosis in the ipsilateral cervical carotid artery. It is uncertain whether immediate carotid artery stenting (CAS) of a cervical carotid artery stenosis during endovascular thrombectomy (EVT) is beneficial. Immediate CAS could improve cerebral perfusion and prevent recurrent ischemic stroke but could also increase the chance of intracranial hemorrhagic complications due to hyperperfusion syndrome or to the required antiplatelet treatment to prevent stent occlusion. Moreover, some patients end up with a severe disabling stroke after EVT. In these patients carotid revascularization by carotid endarterectomy (CEA) or CAS would usually not be performed but these patients would be treated by medical management only.
Objective: to assess the safety and efficacy of immediate cervical CAS during EVT in patients with acute ischemic stroke due to LVO with a high-grade stenosis >50% or occlusion of the ipsilateral cervical carotid artery.
Study design: prospective randomized open label controlled trial comparing immediate CAS during EVT versus EVT with deferred treatment of the cervical carotid artery lesion (deferred CAS/CEA or medical management alone). Outcome assessment will be blinded for treatment allocation.
Read the detailed description
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 (www.contrast-consortium.nl).
The study is funded by the BeNeFIT funding members (ZonMw/KCE) (the Netherlands)
- Conditions
- Stroke, Acute, Stroke, Ischemic, Carotid Stenosis, Carotid Atherosclerosis, Carotid Occlusion
- Being tested
- carotid artery stenting during EVT, no carotid artery stenting during EVT
- Medical subject headings
- Stroke, Ischemic Stroke, Carotid Stenosis, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carotid artery stenting during EVTProcedure or surgery
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).
no carotid artery stenting during EVTOther
A deferred treatment approach: carotid revascularization within two weeks after stroke onset or best medical management only, depending on the functional recovery of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Carotid artery stenting during endovascular thrombectomy | Experimental | 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) Receives: Procedure: carotid artery stenting during EVT |
| No immediate carotid artery stenting during endovascular thrombectomy | Active comparator | 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) Receives: Other: no carotid artery stenting during EVT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale score
Stroke-related disability measured using the Modified Rankin Scale (mRS) Score at 90 days after stroke onset.
Measured: 90 days
Secondary outcomes (9)
NIHSS score 24 hours
Stroke severity
Measured: 24 hours
TICI score
Recanalization after EVT
Measured: during EVT
Final infarct volume on brain CT scan at 24 hours
Final infarct volume on brain CT scan at 24 hours
Measured: 24 hours
Arterial occlusive lesion score at 24 hours
Arterial occlusive lesion score at 24 hours
Measured: 24 hours
Any stroke
Any ischemic, hemorrhagic stroke or TIA
Measured: 90 days
Recurrent ipsilateral TIA/ischemic stroke
Recurrent ipsilateral TIA/ischemic stroke
Measured: 90 days
Carotid re-occlusion
Carotid re-occlusion on CTA at 24 hours or duplex at 90 days
Measured: 24 hours and 90 days
Mortality
Mortality
Measured: 90 days
Quality of Life
Quality of life measured with the EQ5D-5L)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start15 Nov 2022
- Primary completion5 Apr 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Sponsor
- Investigators
- Maarten Uyttenboogaart, MD PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511089
- Sponsor's protocol ID
- NL79046.078.23
- Acronym
- CASES
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://www.contrast-consortium.nl/wp-content/uploads/2021/03/SOP-publications-v1.0.pdf
Publications
Maes L, Van Elk T, van der Meij A, Roelofs F, Bogaerts K, Bokkers RP, de Borst GJ, den Hertog HM, Dippel DW, Francois O, Ligot N, Lingsma HF, Majoie CB, Peluso JP, Tancredi I, van den Wijngaard IR, van der Lugt A, Yperzeele L, Zeebregts CJ, Nederkoorn PJ, Lemmens R, Uyttenboogaart M. Carotid Artery Stenting during Endovascular treatment of acute ischemic Stroke (CASES) study protocol for a multicenter randomized clinical trial. Eur Stroke J. 2025 Sep;10(3):995-1002. doi: 10.1177/23969873251319941. Epub 2025 Feb 16.
PubMed 39957001
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06511089
- Acronym / sponsor ID
- CASES / NL79046.078.23
- Conditions
- Stroke, Acute, Stroke, Ischemic, Carotid Stenosis, Carotid Atherosclerosis, Carotid Occlusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 5 Apr 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: Approximately 20% of the patients with acute ischemic stroke due to an intracranial large vessel occlusion (LVO) has a high-grade stenosis in the ipsilateral cervical carotid artery. It is uncertain whether immediate carotid artery stenting (CAS) of a cervical carotid artery stenosis during endovascular thrombectomy (EVT) is beneficial. Immediate CAS could improve cerebral perfusion and prevent recurrent ischemic stroke but could also increase the chance of intracranial hemorrhagic complications due to hyperperfusion syndrome or to the required antiplatelet treatment to prevent stent occlusion. Moreover, some patients end up with a severe disabling stroke after EVT. In these patients carotid revascularization by carotid endarterectomy (CEA) or CAS would usually not be performed but these patients would be treated by medical management only.
Objective: to assess the safety and efficacy of immediate cervical CAS during EVT in patients with acute ischemic stroke due to LVO with a high-grade stenosis >50% or occlusion of the ipsilateral cervical carotid artery.
Study design: prospective randomized open label controlled trial comparing immediate CAS during EVT versus EVT with deferred treatment of the cervical carotid artery lesion (deferred CAS/CEA or medical management alone). Outcome assessment will be blinded for treatment allocation.
Detailed description
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 (www.contrast-consortium.nl).
The study is funded by the BeNeFIT funding members (ZonMw/KCE) (the Netherlands)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carotid artery stenting during endovascular thrombectomy | Experimental | Procedure: carotid artery stenting during EVTIn 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) |
| No immediate carotid artery stenting during endovascular thrombectomy | Active comparator | Other: no carotid artery stenting during EVTThe 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Acute ischemic stroke due to proximal intracranial occlusion in the anterior circulation (intracranial ICA, M1, proximal M2) on the CT angiography
- Stenosis >50% according to the NASCET criteria16 or initial occlusion of the ipsilateral cervical carotid artery of presumed atherosclerotic origin on baseline CT angiography
- 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)
- Baseline National Institute of Health Stroke Scale (NIHSS) score ≥2
- Age >18 years
Key exclusion criteria (9 listed)
- Any intracranial hemorrhage
- Cervical carotid artery stenosis or occlusion with other causes than presumed atherosclerosis (e.g. carotid artery dissection, floating thrombus, carotid web)
- Any exclusion criterion for EVT according to the guidelines
- Pre stroke disability (defined as a modified Rankin Scale score >2)
- Recent gastro-intestinal or urinary tract hemorrhage (<6 weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carotid artery stenting during EVTPatients 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). | Procedure or surgery | Carotid artery stenting during endovascular thrombectomy |
| no carotid artery stenting during EVTA deferred treatment approach: carotid revascularization within two weeks after stroke onset or best medical management only, depending on the functional recovery of the patient. | Other | No immediate carotid artery stenting during endovascular thrombectomy |
Primary outcome
Modified Rankin Scale score
Time frame: 90 days
Stroke-related disability measured using the Modified Rankin Scale (mRS) Score at 90 days after stroke onset.
9 secondary outcomes
NIHSS score 24 hours
Time frame: 24 hours
TICI score
Time frame: during EVT
Final infarct volume on brain CT scan at 24 hours
Time frame: 24 hours
Arterial occlusive lesion score at 24 hours
Time frame: 24 hours
Any stroke
Time frame: 90 days
Recurrent ipsilateral TIA/ischemic stroke
Time frame: 90 days
Carotid re-occlusion
Time frame: 24 hours and 90 days
Mortality
Time frame: 90 days
Quality of Life
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Derived from this study: PubMed 39957001Maes L, Van Elk T, van der Meij A, Roelofs F, Bogaerts K, Bokkers RP, de Borst GJ, den Hertog HM, Dippel DW, Francois O, Ligot N, Lingsma HF, Majoie CB, Peluso JP, Tancredi I, van den Wijngaard IR, van der Lugt A, Yperzeele L, Zeebregts CJ, Nederkoorn PJ, Lemmens R, Uyttenboogaart M. Carotid Artery Stenting during Endovascular treatment of acute ischemic Stroke (CASES) study protocol for a multicenter randomized clinical trial. Eur Stroke J. 2025 Sep;10(3):995-1002. doi: 10.1177/23969873251319941. Epub 2025 Feb 16.
- trial websiteLink provided by the sponsor.
- Contrast ConsortiumLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://www.contrast-consortium.nl/wp-content/uploads/2021/03/SOP-publications-v1.0.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maarten Uyttenboogaart, MD PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing carotid artery stenting during EVT and no carotid artery stenting during EVT in people with Stroke, Acute and Stroke, Ischemic, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maarten Uyttenboogaart, MD PhD (+31 50 3612400, m.uyttenboogaart@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale score (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06511089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.