Ischemic Stricture of Intestine Clinical Trial
Official title:
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.
;