Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Universitaire Ziekenhuizen KU Leuven | OTHER |
Not provided
Not provided
Not provided
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.
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)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carotid artery stenting during EVT | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale score | Stroke-related disability measured using the Modified Rankin Scale (mRS) Score at 90 days after stroke onset. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| NIHSS score 24 hours | Stroke severity | 24 hours |
| TICI score | Recanalization after EVT | during EVT |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic Intracranial hemorrhage | Symptomatic Intracranial hemorrhage | 24 hours and 90 days |
| Any intracranial hemorrhage | Any intracranial hemorrhage |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maarten Uyttenboogaart, MD PhD | Contact | +31 50 3612400 | m.uyttenboogaart@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| Maarten Uyttenboogaart, MD PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Recruiting | Groningen | 9713 GZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39957001 | Derived | 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. |
| Label | URL |
|---|---|
| trial website | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D016893 | Carotid Stenosis |
| D002340 | Carotid Artery Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
PROBE design
Not provided
|
| no carotid artery stenting during EVT | Other | 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. |
|
| Final infarct volume on brain CT scan at 24 hours | Final infarct volume on brain CT scan at 24 hours | 24 hours |
| Arterial occlusive lesion score at 24 hours | Arterial occlusive lesion score at 24 hours | 24 hours |
| Any stroke | Any ischemic, hemorrhagic stroke or TIA | 90 days |
| Recurrent ipsilateral TIA/ischemic stroke | Recurrent ipsilateral TIA/ischemic stroke | 90 days |
| Carotid re-occlusion | Carotid re-occlusion on CTA at 24 hours or duplex at 90 days | 24 hours and 90 days |
| Mortality | Mortality | 90 days |
| Quality of Life | Quality of life measured with the EQ5D-5L) | 90 days |
| 24 hours and 90 days |
| Contrast Consortium | View source |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001157 | Arterial Occlusive Diseases |