The primary objective of the study is to assess the safety and effectiveness of SPG stimulation with the ISS in a 24 hour window, in patients with an acute ischemic stroke in the anterior circulation, who received Mechanical Thrombectomy and/or IV-rtPA and Standard of Care.
This will be a multi-center, multinational, randomized, double blind, sham control, adjunctive to Standard of Care, parallel arm study and will include ongoing DSMB review of accumulated safety data. The study has three phases: Phase I - Implantation Safety Assessment * Number of patients: 20 (at least 10 implantations) * Implanters: only certified implanters who already performed implantation of ISS in previous studies * Continue to the next phase if there are no serious procedure complications related to IV-rtPA (as determined by the implanter). Otherwise, implement retirements and continue only after DSMB approval. DSMB meetings: after 10 implantations Phase II - Symptomatic Intracranial Hemorrhage Assessment (sICH): * Number of patients: 50 (additional 30) * Implanters: all certified implanters * Verify no clinically meaningful difference between treated and control. A clinically meaningful difference is a difference of more than 3 sICH cases within the first 5 days of treatment, in the treated arm compared to the control arm. In case of clinically meaningful difference, implement retirements. * Continue to phase III after DSMB approval. * DSMB meetings: after 30 and 50 patients Phase III - Entire study population, DSMB meetings at 100 and 150 patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
27
SPG stimulation and standard of care
Sham stimulation and standard of care
Vall d'Hebron
Barcelona, Spain
Distribution of patients across the ordinal modified Rankin scale (mRS)
The primary effectiveness endpoint will be the modified Rankin Scale (mRS) evaluated by the site on Day 90±7. The statistical analysis of the primary effectiveness endpoint will be: Sliding Dichotomous mRS.
Time frame: 90 days
Distribution of patients with NIHSS best language score ≥ 2 at screening across the ordinal modified Rankin scale (mRS)
The secondary effectiveness endpoint will be the modified Rankin Scale (mRS) evaluated by the site on Day 90±7 for patients with NIHSS best language score ≥ 2 at screening. The statistical analysis of the primary effectiveness endpoint will be: Sliding Dichotomous mRS.
Time frame: 90 days
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