Carotid Artery Stenting During Endovascular Treatment of Acute Stroke

NCT06511089 | Recruiting Phase 3 DMC

• 1 other identifier: NL79046.078.23
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale score

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

  90 days

Secondary Outcomes (9)

• NIHSS score 24 hours

  24 hours

• TICI score

  during EVT

• Final infarct volume on brain CT scan at 24 hours

  24 hours

• Arterial occlusive lesion score at 24 hours

  24 hours

• Any stroke

  90 days

Other Outcomes (2)

• Symptomatic Intracranial hemorrhage

  24 hours and 90 days

• Any intracranial hemorrhage

  24 hours and 90 days

Study Arms (2)

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)

Procedure: carotid artery stenting during EVT

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)

Other: no carotid artery stenting during EVT

Interventions

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).

Carotid artery stenting during endovascular thrombectomy

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.

No immediate carotid artery stenting during endovascular thrombectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Any intracranial hemorrhage
• Cervical carotid artery stenosis or occlusion with other causes than presumed atherosclerosis (e.g. carotid artery dissection, floating thrombus, carotid web)
• Pre stroke disability (defined as a modified Rankin Scale score \>2)
• Recent gastro-intestinal or urinary tract hemorrhage (\<6 weeks)
• Recent severe head trauma (\<6 weeks)
• Recent infarction on baseline brain CT in the same vascular territory (\<6 weeks)
• Known allergy to aspirin and/or clopidogrel
• Pregnancy

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 39957001 DERIVED

Related Links

• trial website
• Contrast Consortium

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Carotid Stenosis; Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases

Study Officials

• Maarten Uyttenboogaart, MD PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maarten Uyttenboogaart, MD PhD

CONTACT

+31 50 3612400; m.uyttenboogaart@umcg.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: PROBE design
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: November 15, 2022
• Primary Completion: April 5, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

NL (1)