Evaluation of Acute Mechanical Revascularization in Large Vessel Occlusion Stroke With Minor Symptoms (NIHSS<6) in Patients Last Seen Well < 24 Hours

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Stroke represents the fourth leading cause of death in industrialized nations, after heart disease, cancer, and chronic lower respiratory disease. Approximately one-quarter of the patients suffering a stroke die within one year after the initial event and stroke is a leading cause of serious long-term disability. Although mechanical thrombectomy (MT) has become the standard of care for acute ischemic stroke with proximal large vessel occlusion (LVO) in the anterior circulation, the management of patients harboring proximal occlusion but presenting minor-to-mild stroke symptoms, has not yet been determined by these recent randomized clinical trials. However, patients with proximal occlusions may present with a low NIHSS, a proximal intraarterial occlusion being present in up to 28% when considering patients with an NIHSS ≤ 4. The evidence of benefit from endovascular therapy (EVT) in large vessel occlusion stroke is demonstrated, STAIR IX (Stroke Treatment Academic Industry Roundtable) consensus recommendations were developed that outline priorities for future research in EVT.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Subject is ≥ 18 years old at inclusion (no upper age limit)

• Clinical signs consistent with acute ischemic stroke with time last known well (TLKW) ≤ 23h at randomization (With the goal of remaining within 24 hours from TLKW til treatment)

• Patients NIHSS 0-5 at the time of randomization

• ASPECT ≥ 6 on non-contrast CT or Diffusion Weighted Imaging (DWI)-MRI

• Ischemic Stroke confirmed with cerebral imaging or normal imaging with suspected ischemic stroke

• Proved anterior circulation intracranial large vessel occlusion on CTA or Magnetic resonance angiography (MRA) (ICA, M1, M1-M2, with or without cervical lesion (Tandem))

• Patient or patient's representative has received information about the study and has signed and dated the appropriate Informed Consent Form, or fulfilling the criteria for emergent consent.

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

• Pre stroke mRS ≤ 1

• For Drip and Ship patients : new imaging performed again on inclusion center if first imaging performed \> 1 hour before randomization.

Locations
Other Locations
France
Hopital Gui De Chauliac
RECRUITING
Montpellier
Contact Information
Primary
Caroline ARQUIZAN, PH
c-arquizan@chu-montpellier.fr
4 67 33 75 32
Backup
Bertrand LAPERGUE, PH
bertrand.lapergue@gmail.com
1 46255973
Time Frame
Start Date: 2019-04-10
Estimated Completion Date: 2025-10
Participants
Target number of participants: 824
Treatments
Other: Best Medical Therapy (BMT)
Best treatment medical probably associated to the rescue endovascular treatment in case of neurological deterioration
Other: Mechanical Thrombectomy (MT)
Endovascular treatment (thrombectomy) associated with the best treatment medical
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov