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

Last updated: October 21, 2024
Sponsor: University Hospital, Montpellier
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Blood Clots

Thrombosis

Treatment

Best medical treatment (BMT)

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

Clinical Study ID

NCT05832762
RECHMPL21_0527
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥18-year-old patients (no upper age limit)

  • Clinical signs consistent with AIS (Acute ischemic stroke), and time from last seenwell to randomization ≤23h

  • NIHSS score >5 at randomization time

  • Ischemic stroke confirmed by cerebral imaging (CT: Computed Tomography orMRI:Magnetic Resonance Imaging) or normal imaging with suspected ischemic stroke

  • Existence of a mismatch: If perfusion data are available (PWI/CTP), existence of acore-perfusion mismatch, suggestive of carotid hemodynamic mechanism, according tothe DEFUSE-3 criteria: mismatch volume ≥15 mL, core volume ≤70 mL, and mismatchratio ≥1.8 ; if perfusion data are not available, or non interpretable, existence ofa clinical-imaging mismatch, defined by an ASPECTS >5 (Alberta Stroke Program EarlyCT score)

  • CICAO (Cervical isolated Internal Carotid Artery Occlusion) on CTA (ComputedTomography Angiography) or MRA with gadolinium, without associated visibleipsilateral large intracranial occlusion (T or L, M1, M2, A1, A2, P1, P2), <1 hbefore randomization

  • Anticipated possibility to start the EVT procedure (arterial access) within 60minutes after randomization

  • Pre-stroke mRS score ≤2

  • Patient or patient's representative has received information about the study and hassigned and dated the appropriate Informed Consent or met the criteria for emergencyconsent, signed by the investigator

Exclusion

Exclusion Criteria:

  • CICAO after recent (<1 month) endarterectomy

  • Patient with severe or fatal co-morbidities or life expectancy <6 months that willlikely interfere with improvement or follow-up or that will render the procedureunlikely to benefit the patient

  • Patient unable to come or unavailable for follow-up

  • Pre-existing neurological or psychiatric disease that would confound theneurological or functional evaluations

  • Seizures at stroke onset if they make the diagnosis of stroke doubtful and precludeobtaining an accurate baseline NIHSS assessment

  • Suspected cerebral vascular disease (e.g., vasculitis) based on the medical historyand CTA/MRA

  • Pregnancy in progress or planned during the study period, woman who is known to bepregnant 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 suchsystem

  • 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) ≥30days before randomization or high suspicion of chronic CICAO based on medicalhistory and CT/MRI

  • Tandem occlusion, defined by cervical ICA occlusion associated with intracraniallarge vessel occlusion (T- or L-shaped, M1 or M2 portions of the middle cerebralartery, A1 or A2 portions of the anterior cerebral artery, P1 or P2 portions of theposterior 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 intracranialsegment 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/andimaging

  • Sub-occlusive cervical ICA stenosis on CTA or MRA

  • Common carotid artery occlusion without ICA occlusion on non-invasive imaging (MRAor/and CTA)

  • Evidence of intracranial hemorrhage on CT/MRI.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Best medical treatment (BMT)
Phase:
Study Start date:
August 19, 2024
Estimated Completion Date:
November 01, 2026

Study Description

The primary objective of this study is to demonstrate the superiority of endovascular therapy (EVT) associated with best medical therapy (BMT) (experimental arm) compared to BMT alone (control arm) to increase the functional independence at day 90 3 months (mRS 0-2) 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 in patients with AIS secondary to CICAO and core-perfusion of clinical imaging mismatch; (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 decrease of the 90-day degree of disability (shift on the mRS combining scores of 5 and 6), the rate of carotid recanalization at 24 hours and at day 90 post-randomization, the cerebral infarct size at 24 hours and at day 90 post-randomization, the early neurological deterioration rate at 24 hours and at day 5- 7 post-randomization, the ischemic recurrences rate at day 90 post-randomization, the early neurological improvement rate at 24h hours post-randomization, the cognitive impairment rate at day 90 post-randomization, the Quality of life 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 at day 90 ((Embolism to an intracranial artery, vascular perforation, arterial dissection, access site complication requiring surgical repair or blood transfusion, peri-procedural mortality, device failure).

Connect with a study center

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

    Montpellier, Fance
    France

    Active - Recruiting

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