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Evaluation of Acute Endovascular Treatment in Symptomatic Isolated Cervical Internal Carotid Artery Occlusion Within 24 Hours of Last Seen Well (ETICA) (ETICA)

Primary Purpose

Ischemic Stroke, Acute

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Endovascular treatment (EVT) + Best medical treatment (BMT)
Best medical treatment (BMT)
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke, Acute focused on measuring Acute ischemic Stroke; Mechanical Thrombectomy; Carotid artery; Stenting, randomized trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≥18-year-old patients (no upper age limit) Clinical signs consistent with AIS (Acute ischemic stroke), and time from last seen well to randomization ≤23h NIHSS score >5 at randomization time 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, existence of a clinical-imaging mismatch, defined by an ASPECTS >5 (Alberta Stroke Program Early CT score) CICAO (Cervical isolated Internal Carotid Artery Occlusion) 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 after 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. Exclusion Criteria: 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 curatorship Current participation in another investigational drug 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 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 Prior stenting of the target ICA Intracranial stent implanted in the same vascular territory as the CICAO Sub-occlusive cervical ICA stenosis on CTA or MRA Suspicion of ICA occlusion starting at the petrous, cavernous or intracranial segment with normal cervical portion on non-invasive imaging (MRA or/and CTA) Known absence of vascular access Suspicion of aortic dissection based on medical history, clinical evaluation or/and imaging Sub-occlusive cervical ICA stenosis on CTA or MRA Common carotid artery occlusion without ICA occlusion on non-invasive imaging (MRA or/and CTA) Evidence of intracranial hemorrhage on CT/MRI.

Sites / Locations

  • Department of Neurology/ Stroke Unit, Hôpital Gui de Chauliac

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endovascular treatment + best medical treatment

best medical treatment

Arm Description

Endovascular treatment associated with the best medical treatment.

Best medical treatment alone

Outcomes

Primary Outcome Measures

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 (±14), mRS scoring can be done by telephone by a qualified investigator.

Secondary Outcome Measures

Percentage of patients with excellent outcome (mRS score = 0-1)
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 (±14), mRS scoring can be done by telephone by a qualified investigator.
Change in NIHSS score at 24 (-6/+12) hours post-randomization.
NIHSS score is "the National Institutes of Health Stroke Scale". The NIHSS is composed of 11 items, each of which scores a specific ability between 0 and 4. For each item, a score of 0 typically indicates normal function, while higher scores are indicative of some level of impairment. The individual scores for each item are summed to calculate the patient's total NIHSS score. The maximum possible score is 42, and the minimum score is 0.
Quality of life assessed with the EuroQol 5D-5L scale
Assessed with the EuroQol 5D-5L scale. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems
Cognitive function at day 90 (±14), evaluated with the MoCA test.
The MoCA test is the Montreal Cognitive Assessment mesuring the neurocognitive function. There are 30 questions covering orientation, short-term memory, focus and spatial awareness, language, concentration and clock drawing test.
Ischemic recurrence rate
Ischemic recurrence rate
Ischemic recurrence rate
Ischemic recurrence rate
Ischemic recurrence rate
Ischemic recurrence rate
Carotid artery revascularization rate
Assessed by angiography in the treatment arm, defined by complete recanalization or residual carotid artery stenosis <50%
Carotid artery recanalization rate
Assessed by MRA with gadolinium or CTA, defined as complete recanalization or residual carotid artery stenosis <50%
Carotid artery recanalization rate
Assessed by MRA with gadolinium or CTA, defined as complete recanalization or residual carotid artery stenosis <50%
Infarct volume
Mesured by magnetic resonance angiography (MRI, FLAIR) or computed tomography (CT).
Infarct volume
Mesured by magnetic resonance angiography (MRI, FLAIR) or computed tomography (CT).
Early neurological improvement
Early neurological improvement is defined by an NIHSS score of 0-2 at 24 hours or a ≥8-point decrease of the NIHSS score at 24 hours compared with baseline.
Incidence of all-cause mortality at day 90
Incidence of all-cause mortality at day 90
Incidence of symptomatic intracranial hemorrhage
According to the Heidelberg Bleeding classification by brain imaging
Incidence of procedure/device-related adverse events
In the experimental group (EVT + BMT)
Early neurological deterioration rate
NIHSS score increase by ≥4 points
Neurological deterioration rate
NIHSS score increase by ≥4 points
Rapid NIHSS worsening
NIHSS score increase by ≥10 points

Full Information

First Posted
April 14, 2023
Last Updated
April 14, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT05832762
Brief Title
Evaluation of Acute Endovascular Treatment in Symptomatic Isolated Cervical Internal Carotid Artery Occlusion Within 24 Hours of Last Seen Well (ETICA)
Acronym
ETICA
Official Title
Evaluation of Acute Endovascular Treatment in Symptomatic Isolated Cervical Internal Carotid Artery Occlusion Within 24 Hours of Last Seen Well
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 patient with mild or severe AIS and diffusion-perfusion or clinical-imaging mismatch, secondary to CICAO.
Detailed Description
The primary objective of this study is to demonstrate the superiority of endovascular therapy (EVT) associated with best medical therapy (BMT) compared to BMT alone to increase the functional independence at 3 months in patients with acute cervical isolated internal carotid artery occlusion (CICAO), mild to severe stroke (NIHSS score > 5), and core-perfusion or clinical-imaging mismatch. Secondary objectives are,(i) to compare the safety of EVT + BMT vs. BMT alone; (ii) to demonstrate the superiority of EVT + BMT vs BMT alone on : the rate of excellent outcome at 3 months (modified Rankin Scale, mRS, score = 0-1), the rate of recanalization at 24 hours and at day 90 post-randomization, the cerebral infarct size at 24 hours post-randomization, the early neurological deterioration rate at 24 hours and at day 7 post-randomization, the ischemic recurrences rate at day 90 post-randomization, the cognitive impairment rate at day 90 post-randomization. One of the secondary objective is also to describe in the experimental group (EVT + BMT), the procedure-related adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Acute
Keywords
Acute ischemic Stroke; Mechanical Thrombectomy; Carotid artery; Stenting, randomized trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The protocol is a national, multi-center, prospectively randomized into two parallel (1:1) arms, open to treatment with blinded endpoint trial (PROBE)
Masking
Outcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endovascular treatment + best medical treatment
Arm Type
Experimental
Arm Description
Endovascular treatment associated with the best medical treatment.
Arm Title
best medical treatment
Arm Type
Active Comparator
Arm Description
Best medical treatment alone
Intervention Type
Procedure
Intervention Name(s)
Endovascular treatment (EVT) + Best medical treatment (BMT)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Best medical treatment (BMT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of patients with favorable functional outcome, defined by a mRS score ≤2
Description
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 (±14), mRS scoring can be done by telephone by a qualified investigator.
Time Frame
Day 90 (± 14 days) post-randomization
Secondary Outcome Measure Information:
Title
Percentage of patients with excellent outcome (mRS score = 0-1)
Description
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 (±14), mRS scoring can be done by telephone by a qualified investigator.
Time Frame
Day 90 (± 14 days) post-randomization
Title
Change in NIHSS score at 24 (-6/+12) hours post-randomization.
Description
NIHSS score is "the National Institutes of Health Stroke Scale". The NIHSS is composed of 11 items, each of which scores a specific ability between 0 and 4. For each item, a score of 0 typically indicates normal function, while higher scores are indicative of some level of impairment. The individual scores for each item are summed to calculate the patient's total NIHSS score. The maximum possible score is 42, and the minimum score is 0.
Time Frame
24h (-6/+12) post-randomization
Title
Quality of life assessed with the EuroQol 5D-5L scale
Description
Assessed with the EuroQol 5D-5L scale. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems
Time Frame
Day 90 (± 14 days) post-randomization
Title
Cognitive function at day 90 (±14), evaluated with the MoCA test.
Description
The MoCA test is the Montreal Cognitive Assessment mesuring the neurocognitive function. There are 30 questions covering orientation, short-term memory, focus and spatial awareness, language, concentration and clock drawing test.
Time Frame
Day 90 (±14 days) post randomization
Title
Ischemic recurrence rate
Description
Ischemic recurrence rate
Time Frame
Day 5-7 post randomization
Title
Ischemic recurrence rate
Description
Ischemic recurrence rate
Time Frame
day 30 (±5) post randomization
Title
Ischemic recurrence rate
Description
Ischemic recurrence rate
Time Frame
day 90 (±14) post randomization
Title
Carotid artery revascularization rate
Description
Assessed by angiography in the treatment arm, defined by complete recanalization or residual carotid artery stenosis <50%
Time Frame
randomization
Title
Carotid artery recanalization rate
Description
Assessed by MRA with gadolinium or CTA, defined as complete recanalization or residual carotid artery stenosis <50%
Time Frame
24 (-6/+12) hours post randomization
Title
Carotid artery recanalization rate
Description
Assessed by MRA with gadolinium or CTA, defined as complete recanalization or residual carotid artery stenosis <50%
Time Frame
Day 90 (± 14 days) post-randomization
Title
Infarct volume
Description
Mesured by magnetic resonance angiography (MRI, FLAIR) or computed tomography (CT).
Time Frame
24 (-6/+12) hours post randomization
Title
Infarct volume
Description
Mesured by magnetic resonance angiography (MRI, FLAIR) or computed tomography (CT).
Time Frame
Day 90 (± 14 days) post randomization
Title
Early neurological improvement
Description
Early neurological improvement is defined by an NIHSS score of 0-2 at 24 hours or a ≥8-point decrease of the NIHSS score at 24 hours compared with baseline.
Time Frame
Day 0 - 24 hours post randomization
Title
Incidence of all-cause mortality at day 90
Description
Incidence of all-cause mortality at day 90
Time Frame
Day 90 (± 14 days) post randomization
Title
Incidence of symptomatic intracranial hemorrhage
Description
According to the Heidelberg Bleeding classification by brain imaging
Time Frame
24 (-6/+12) hours post-randomization
Title
Incidence of procedure/device-related adverse events
Description
In the experimental group (EVT + BMT)
Time Frame
Day 30 (±5 days) post randomization
Title
Early neurological deterioration rate
Description
NIHSS score increase by ≥4 points
Time Frame
24 hours post-randomization
Title
Neurological deterioration rate
Description
NIHSS score increase by ≥4 points
Time Frame
Day 5-7 post randomization
Title
Rapid NIHSS worsening
Description
NIHSS score increase by ≥10 points
Time Frame
Admission - day 5/day 7/discharge (if earlier)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥18-year-old patients (no upper age limit) Clinical signs consistent with AIS (Acute ischemic stroke), and time from last seen well to randomization ≤23h NIHSS score >5 at randomization time 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, existence of a clinical-imaging mismatch, defined by an ASPECTS >5 (Alberta Stroke Program Early CT score) CICAO (Cervical isolated Internal Carotid Artery Occlusion) 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 after 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. Exclusion Criteria: 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 curatorship Current participation in another investigational drug 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 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 Prior stenting of the target ICA Intracranial stent implanted in the same vascular territory as the CICAO Sub-occlusive cervical ICA stenosis on CTA or MRA Suspicion of ICA occlusion starting at the petrous, cavernous or intracranial segment with normal cervical portion on non-invasive imaging (MRA or/and CTA) Known absence of vascular access Suspicion of aortic dissection based on medical history, clinical evaluation or/and imaging Sub-occlusive cervical ICA stenosis on CTA or MRA Common carotid artery occlusion without ICA occlusion on non-invasive imaging (MRA or/and CTA) Evidence of intracranial hemorrhage on CT/MRI.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline ARQUIZAN, Medical Doctor
Phone
0033467330204
Email
c-arquizan@chu-montpellier.fr
Facility Information:
Facility Name
Department of Neurology/ Stroke Unit, Hôpital Gui de Chauliac
City
Montpellier
Country
France

12. IPD Sharing Statement

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Evaluation of Acute Endovascular Treatment in Symptomatic Isolated Cervical Internal Carotid Artery Occlusion Within 24 Hours of Last Seen Well (ETICA)

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