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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥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, 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) 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

Locations
Other Locations
France
Department of Neurology/ Stroke Unit, Hôpital Gui de Chauliac
RECRUITING
Montpellier
Contact Information
Primary
Caroline ARQUIZAN, Medical Doctor
c-arquizan@chu-montpellier.fr
0033467330204
Backup
COSTALAT Vincent, Medical Doctor
v-costalat@chu-montpellier.fr
0033467337532
Time Frame
Start Date: 2024-08-19
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 200
Treatments
Experimental: Endovascular treatment + best medical treatment
Endovascular treatment associated with the best medical treatment.
Active_comparator: best medical treatment
Best medical treatment alone
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov