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Carotid Artery Stenting During Endovascular Treatment of Acute Stroke

NCT06511089 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2024-07-19

No results posted yet for this study

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 CAS/CEA or medical management alone). Outcome assessment will be blinded for treatment allocation.

Conditions

  • Stroke, Acute
  • Stroke, Ischemic
  • Carotid Stenosis
  • Carotid Atherosclerosis
  • Carotid Occlusion

Interventions

PROCEDURE

carotid artery stenting during EVT

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).

OTHER

no carotid artery stenting during EVT

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.

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Maarten Uyttenboogaart, MD PhD · University Medical Center Groningen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2026-04-05
Completion
2026-11-15

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06511089 on ClinicalTrials.gov