Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Ischemia
Study type: Interventional

Summary: 
      The primary objective of the study is to assess the safety and effectiveness of SPG
      stimulation with the ISS in patients with an acute ischemic stroke in the anterior
      circulation initiated within 24 hours from stroke onset.
    

Detailed description: 
      A multi-center, multinational, randomized, blinded, sham control, adjunctive to Standard of
      Care, parallel arm study and will include ongoing Data Safety and Monitoring Board (DSMB)
      review of accumulated safety data.

      Screening:

      Since the treatment should be initiated within 24 hours from stroke onset, the screening
      window is limited and all procedures should be performed within this window.Subjects with
      Acute Ischemic Stroke will be screened upon arrival to the hospital. Since the treatment
      should be initiated between 8 and 24 hours from stroke onset, the screening window is limited
      and all procedures should be performed as soon as possible. All screened patients will be
      identified by patient number and will sign the informed consent prior to any study procedure
      initiation.

      Period 1: Day 1-5

      Day 1- Eligible subjects will be randomized to:

        -  Group 1: Implantation and ISS Stimulation during five consecutive days & Standard of
           Care

        -  Group 2: Sham Implantation and Sham Stimulation during five consecutive days & Standard
           of Care Subjects will be transferred to the implantation procedure facility and the
           implantation/sham implantation will be performed by a trained physician.

      After implantation, active/sham stimulation will be administered in daily 4-hour sessions,
      beginning immediately following the placement procedure and continuing for 5 consecutive
      days.

      Day 5 / Day of Discharge. Following the last ISS /Sham Stimulation, explantation will be
      performed and the patients will be evaluated for safety and effectiveness.

      Subjects will continue with Standard of Care as needed and will be released from the hospital
      upon investigator's judgment.

      Period 2: Day of Discharge - 89±7 days During this period both groups (ISS Stimulation and
      Sham Control) will be treated according to Standard of Care either at the hospital,
      rehabilitation center or at home.

      Scheduled visits will be performed on day 30±7 and day 60 ±7, which will include safety and
      effectiveness assessments.

      Final Visit Day 90±7 days: The final visit will be performed at the study site and will
      include safety and effectiveness evaluations.

      Patients will be contacted by study personnel via telephone on Day 180±7 and on Day 360±7 in
      order to assess their quality of life status.
    

Intervention name(s): Active Sphenopalatine Ganglion (SPG) Stimulation; Sham Sphenopalatine Ganglion (SPG) Stimulation
Intervention type(s): Device; Device
Intervention description(s): SPG stimulation and standard of care. During all study periods, patients will receive Standard of Care in accordance to the general management of ischemic stroke and secondary prevention, following the guidelines of the American Heart Association/American Stroke Association and of the European Stroke Organization (ESO), including the use of antiplatelets, management of secondary stroke, dyslipidemia, hypertension, diabetes and counseling regarding smoking cessation. Off-label uses of drugs and devices should not occur during any of the study periods.; Sham SPG stimulation and standard of care. During all study periods, patients will receive Standard of Care in accordance to the general management of ischemic stroke and secondary prevention, following the guidelines of the American Heart Association/American Stroke Association and of the European Stroke Organization (ESO), including the use of antiplatelets, management of secondary stroke, dyslipidemia, hypertension, diabetes and counseling regarding smoking cessation. Off-label uses of drugs and devices should not occur during any of the study periods.
Other intervention name(s): Standard of Care; Standard of Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acute ischemic stroke; randomized clinical trial; effectiveness; safety