Implant for Augmentation of Cerebral Blood Flow Trial-1. A Pilot Study Evaluating the Safety and Effectiveness of the Ischemic Stroke System for Treatment of Acute Ischemic Stroke
Implant for Augmentation of Cerebral Blood Flow Trial-1. A Pilot Study Evaluating the Safety and Effectiveness of the Ischemic Stroke System for Treatment of Acute Ischemic Stroke
The primary objective of this pilot study is the assessment of the safety of the ISS500 System in patients who have experienced an acute ischemic stroke within the anterior circulation.
The secondary objectives of this study are to examine the effectiveness of the ISS500 System implantation in the treatment of acute ischemic stroke.
The study is an open label study in which a comparative group of patients will be prospectively selected from a resource of clinical trial data, the Virtual International Stroke Trials Archive (VISTA), on the basis of similar eligibility criteria and match for principal prognostic variables available at trial entry. Data from patients will be transferred to VISTA in a real time or at most, weekly basis and comparative group patients will be prospectively matched throughout the recruitment period. The VISTA investigators will be blinded to treatment group when receiving data from BrainsGate. The VISTA investigators will match each recruited BrainsGate patient with 3 patients from the VISTA archive. The matching criteria will include age ± 4 years; baseline NIH score matched exactly, and side of infarct.
In addition, to the end of treatment visit, in which implanted patients will undergo a device removal procedure, two follow-up visits will be performed. The visits should be performed at 30±5, and at 90±5 post enrollment. Aggregate trial duration will be ~100 days per patient, and the overall study duration will be up to 18 months.
Inclusion Criteria:
Exclusion Criteria:
Time interval since onset of symptoms undetermined
Treatment with ISS500 System can't start within the first 24 hours post stroke onset
Any other imaging diagnosis including tumor, abscess, primary intracranial hemorrhage (ICH) or secondary hemorrhage (PH1-PH2) (H1 and H2 are allowed); or symptoms suspicious for sub-arachnoid hemorrhage, etc
Clinical syndrome of an acute stroke due to lacunar infarct (pure motor hemiparesis, ataxic hemiparesis, sensorimotor stroke), unless brain imaging demonstrates a relevant lesion > 1.5 cm in size
Not a stroke in the anterior circulation
Minor stroke with non-disabling deficit or rapidly improving neurological symptoms with a high probably to Transient Ischemic Attack (TIA)
Eligible to or treated with IV or IA t-PA or mechanical thrombolysis
Baseline NIHSS >20 or < 7
Neurological deficit that has led to stupor or coma (NIHSS level of consciousness score greater than or equal to 2)
History of stroke in previous 6 months
Pre-existing disability; Modified Rankin Score > 2 upon screening
Patients under oral anticoagulants or having received heparin within 48 hours, and / or with elevated activated partial thromboplastin time (aPTT) (or INR)
High clinical suspicion of septic embolus
Severe cardiac disease: evidence of congestive heart failure or has history of endstage cardiovascular disease (e.g. CHF NYHA Class III or IV or unstable angina)
Uncontrolled hypertension upon enrollment (systolic >185 mmHg and/or diastolic >110 mmHg)
Serious systemic infection
Women known to be pregnant or having a positive or indeterminate pregnancy test
Patients with other implanted neural stimulator
Orthodontics or non-Hygienic condition/ problems that prevent procedures within the mouth
MRI2 contraindications, such as but not limited to:
Life expectancy < 1 year from other causes
Currently participating in any other clinical trial
Patients unable or unwilling to follow protocol requirements
Massive stroke, defined as acute parenchymal hypodense lesion or effacement of cerebral sulci in over a 2/3 of the MCA territory per CT (or equivalent per T2/Flair/DWI MRI)