Carotid Artery Stenting During Endovascular Treatment of Acute Stroke

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • carotid artery stenting during EVT

    Procedure/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 EVT

    Other intervention

    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.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Carotid artery stenting during endovascular thrombectomyExperimental treatment 1 intervention
Group B: No immediate carotid artery stenting during endovascular thrombectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Modified Rankin Scale score

Stroke-related disability measured using the Modified Rankin Scale (mRS) Score at 90 days after stroke onset.

Time frame
90 days

Secondary outcomes

1

NIHSS score 24 hours

Stroke severity

Time frame
24 hours
2

TICI score

Recanalization after EVT

Time frame
during EVT
3

Final infarct volume on brain CT scan at 24 hours

Final infarct volume on brain CT scan at 24 hours

Time frame
24 hours
4

Arterial occlusive lesion score at 24 hours

Arterial occlusive lesion score at 24 hours

Time frame
24 hours

Other outcomes

1

Symptomatic Intracranial hemorrhage

Symptomatic Intracranial hemorrhage

Time frame
24 hours and 90 days
2

Any intracranial hemorrhage

Any intracranial hemorrhage

Time frame
24 hours and 90 days

Sponsors and contacts

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University Medical Center Groningen

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborator