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
Location: See location...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Netherlands
University Medical Center Groningen
RECRUITING
Groningen
Contact Information
Primary
Maarten Uyttenboogaart, MD PhD
m.uyttenboogaart@umcg.nl
+31 50 3612400
Time Frame
Start Date: 2022-11-15
Estimated Completion Date: 2026-11-15
Participants
Target number of participants: 600
Treatments
Experimental: Carotid artery stenting during endovascular thrombectomy
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)
Active_comparator: No immediate carotid artery stenting during endovascular thrombectomy
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)
Sponsors
Collaborators: Universitaire Ziekenhuizen KU Leuven
Leads: University Medical Center Groningen

This content was sourced from clinicaltrials.gov