Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511089
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Carotid Artery Stenting During Endovascular Treatment of Acute Stroke
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CASES
Brief 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 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 CASCEA or medical management alone Outcome assessment will be blinded for treatment allocation
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 CASCEA 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 wwwcontrast-consortiumnl
The study is funded by the BeNeFIT funding members ZonMwKCE the Netherlands
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 wwwcontrast-consortiumnl
The study is funded by the BeNeFIT funding members ZonMwKCE the Netherlands
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None