A Multi-center, Rand., Double Blind, Sham Control, Parallel Arm Post Mech. Thrombectomy and/or rtPA Trial to Assess Safety and Effectiveness of the Ischemic Stroke System, as an Adjunct to Stand. of Care in Subjects With Acute Isch. Stroke
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Ischemic Stroke
- Sponsor
- BrainsGate
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Distribution of patients across the ordinal modified Rankin scale (mRS)
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: ≥ 40 years and ≤ 80 years for male and 85 for female subjects
- •Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior Cerebral Artery territories based on general physical examination and neurological examination.
- •Imaging findings demonstrating signs of ischemia (or total arterial occlusion prior to the MT procedure) in the anterior circulation, consistent with the clinical diagnosis.
- •Performance of MT within \<8 hours from stroke onset and/or administration of IV-rtPA within ≤ 4.5 hours from stroke onset.
- •NIHSS ≥ 7 and ≤ 18 within 2 hours prior to implantation.
- •Ability to initiate treatment within
- •≤ 24 hours from stroke onset.
- •Signed informed consent from patient him/herself or legally authorized representative if applicable.
Exclusion Criteria
- •Neuro-imaging evidence of any intracranial hemorrhage (including suspect of Sub Arachnoid Hemorrhage) or hemorrhagic transformation of brain infarct or other significant abnormality (e.g. tumor, abscess)
- •Massive stroke, defined as acute parenchymal lesion with effacement of cerebral sulci in over 2/3 of the MCA territory.
- •Acute stroke due to lacunar infarct as defined by a clinical syndrome (pure motor hemiparesis, ataxic hemiparesis, sensorimotor stroke, dysarthria-clumsy hand syndrome), unless brain imaging demonstrates a relevant lesion \> 1.5 cm in size.
- •Clinical signs and symptoms or evidence for a relevant lesion by neuro-imaging of an acute ischemic stroke in the posterior circulation (Vertebral, Basilar and/or Posterior Cerebral Artery territories), including but not limited to brain-stem findings and/or cerebellar findings and/or isolated homonymous hemianopia or cortical blindness.
- •Minor stroke with non-disabling deficit or rapidly improving neurological symptoms.
- •Clinical signs and symptoms or imaging evidence of bilateral stroke.
- •Treated with IA-rtPA for the current stroke.
- •Complicated MT procedure (including procedures with more than 3 clot removal attempts (catheter passes), or MT procedure that lasted more than 2 hours)
- •NIHSS level of consciousness score ≥
- •Previous stroke in the last 6 months or previous stroke with existing sequelae or with mRS \> 0 for any reason
Outcomes
Primary Outcomes
Distribution of patients across the ordinal modified Rankin scale (mRS)
Time Frame: 90 days
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.
Secondary Outcomes
- Distribution of patients with NIHSS best language score ≥ 2 at screening across the ordinal modified Rankin scale (mRS)(90 days)