Evaluation of Acute Endovascular Treatment in Symptomatic Isolated Cervical Internal Carotid Artery Occlusion (ETICA)

NCT05832762 | Recruiting

• 1 other identifier: RECHMPL21_0527
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Our main hypothesis is that acute EVT associated with best medical treatment is superior to best medical treatment alone, for improving clinical outcomes at 90 days, in patients with mild or severe acute ischemique stroke and diffusion-perfusion or clinical-imaging mismatch, secondary to CICAO.

Conditions

Acute Ischemic Stroke

Keywords

Acute ischemic Stroke; Mechanical Thrombectomy; Carotid artery; Stenting; Randomized trial

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with favorable functional outcome, defined by a mRS score ≤2

  The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.The scale runs from "0" to "6", running from perfect health without symptoms to death. The mRS score will be evaluated by qualified assessors blinded to the initial treatment.The blinded evaluator must be familiar with mRS scoring (dedicated training and certification). If a participant is unable to attend in-person the follow-up visit at day 90 (±15), mRS scoring can be done by telephone by a qualified investigator.

  Day 90 (± 15 days) post-randomization

Secondary Outcomes (18)

• The degree of disability at day 90 (±15) post-randomization (shift on the mRS combining scores of 5 and 6)

  Day 90 (± 15 days) post-randomization

• Change in NIHSS score at 24 (-6/+12) hours post-randomization.

  24h (-6/+12) post-randomization

• Quality of life at day 90 (±15) post-randomization assessed with the EuroQol 5D-5L

  Day 90 (± 15 days) post-randomization

• Cognitive function at day 90 (±15) post-randomization, evaluated with the Montreal Cognitive assessment (MoCA test).

  Day 90 (±15 days) post randomization

• Carotid artery revascularization rate

  randomization

Study Arms (2)

Endovascular treatment + best medical treatment

EXPERIMENTAL

Endovascular treatment associated with the best medical treatment.

Procedure: Endovascular treatment (EVT) + Best medical treatment (BMT)

best medical treatment

ACTIVE COMPARATOR

Best medical treatment alone

Procedure: Best medical treatment (BMT)

Interventions

Endovascular treatment (EVT) + Best medical treatment (BMT) PROCEDURE

Endovascular treatment (EVT) in the experimental arm can be performed with any recanalization strategy based on the operator's choice, and anatomical and radiological situation: MT using aspiration or stent retriever, with or without stenting (CE-labelled) or angioplasty. In case of acute stenting, the use of antiplatelet drugs will be based on the operator's preference, anatomical situation, and risk of hemorrhage. Best medical treatment (BMT) : Administration of drugs is at the treating physician's discretion (for example, intravenous fibrinolysis, anticoagulants, or antiplatelet agents) according to the local standards of care, but not intra-arterial therapies.

Endovascular treatment + best medical treatment

Best medical treatment (BMT) PROCEDURE

Administration of drugs is at the treating physician's discretion (for example, intravenous fibrinolysis, anticoagulants, or antiplatelet agents) according to the local standards of care, but not intra-arterial therapies.

best medical treatment

Eligibility Criteria

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

You may qualify if:

• ≥18-year-old patients (no upper age limit)
• Clinical signs consistent with AIS (Acute ischemic stroke)
• NIHSS score \>5 at randomization time with time from last seen well to randomization ≤23h, or fluctuating neurological symptoms, defined as recurrent transient attacks and/or progression of neurological deficit within the last 7 days.
• Ischemic stroke confirmed by cerebral imaging (CT: Computed Tomography or MRI:Magnetic Resonance Imaging) or normal imaging with suspected ischemic stroke
• Existence of a mismatch: If perfusion data are available (PWI/CTP), existence of a core-perfusion mismatch, suggestive of carotid hemodynamic mechanism, according to the DEFUSE-3 criteria: mismatch volume ≥15 mL, core volume ≤70 mL, and mismatch ratio ≥1.8 ; if perfusion data are not available, or non interpretable, existence of a clinical-imaging mismatch, defined by an ASPECTS \>5 (Alberta Stroke Program Early CT score)
• CICAO (Cervical isolated Internal Carotid Artery Occlusion) all causes (for example dissection, atheroma or undetermined cause) on CTA (Computed Tomography Angiography) or MRA with gadolinium, without associated visible ipsilateral large intracranial occlusion (T or L, M1, M2, A1, A2, P1, P2), \<1 h before randomization
• Anticipated possibility to start the EVT procedure (arterial access) within 60 minutes after randomization
• Pre-stroke mRS score ≤2
• Patient or patient's representative has received information about the study and has signed and dated the appropriate Informed Consent or met the criteria for emergency consent, signed by the investigator

You may not qualify if:

• CICAO after recent (\<1 month) endarterectomy
• Patient with severe or fatal co-morbidities or life expectancy \<6 months that will likely interfere with improvement or follow-up or that will render the procedure unlikely to benefit the patient
• Patient unable to come or unavailable for follow-up
• Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations
• Seizures at stroke onset if they make the diagnosis of stroke doubtful and preclude obtaining an accurate baseline NIHSS assessment
• Suspected cerebral vascular disease (e.g., vasculitis) based on the medical history and CTA/MRA
• Pregnancy in progress or planned during the study period, woman who is known to be pregnant or lactating at admission time
• Adult protected by law or patient under guardianship or curators
• Current participation in another investigational drug or device study
• Not affiliated to the French social security system or not beneficiary of such system
• Known contrast or endovascular product life-threatening allergy
• Associated stenosis (≥50%) of the middle cerebral artery ipsilateral to the CICAO
• Chronic CICAO, defined as a known carotid occlusion (on a previous imaging exam) ≥30 days before randomization or high suspicion of chronic CICAO based on medical history and CT/MRI
• Tandem occlusion, defined by cervical ICA occlusion associated with intracranial large vessel occlusion (T- or L-shaped, M1 or M2 portions of the middle cerebral artery, A1 or A2 portions of the anterior cerebral artery, P1 or P2 portions of the posterior cerebral artery)
• Associated ipsilateral large intracranial arterial occlusion

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Department of Neurology/ Stroke Unit, Hôpital Gui de Chauliac

Montpellier, Fance, France

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Caroline ARQUIZAN, Medical Doctor

CONTACT

0033467330204; c-arquizan@chu-montpellier.fr

COSTALAT Vincent, Medical Doctor

CONTACT

0033467337532; v-costalat@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: As the therapeutic arm is interventional in the experimental arm, the physicians in charge of the patient and the patients cannot be blinded. The mRS score will be evaluated by qualified assessors blinded to the initial treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The protocol is a national, multi-center, prospectively randomized into two parallel (1:1) arms, open to treatment with blinded endpoint trial (PROBE)

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 27, 2023
• Study Start: August 19, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

FR (1)