ImpACT-24B(Implant Augmenting Cerebral blood flow) Rev 1.0

• Research type

  Research Study

• Full title

  ImpACT-24B trial (Implant Augmenting Cerebral Blood Flow Trial 24 hours from stroke onset) A Multicenter, Randomized, Double Blind, Sham Control, Parallel Arm Trial to Assess Safety and Effectiveness of the Ischemic Stroke System ISS, as an Adjunct to Standard of Care in Subjects with Acute Ischemic Stroke

• IRAS ID

  171073

• Contact name

  Eyal Ozeri

• Contact email

  EyalO@brainsgate.com

• Sponsor organisation

  BrainsGate

• Clinicaltrials.gov Identifier

  NCT00826059

• Duration of Study in the UK

  2 years, 10 months, 1 days

• Research summary

  ImpACT-24B- Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window

  BrainsGate is conducting its worldwide Investigational Device Pivotal (Phase III) clinical study to demonstrate the safety and effectiveness of the Ischemic Stroke System (ISS) for the treatment of acute ischemic stroke within the first 24 hours of stroke onset. The ISS consists of an implanted neurostimulator and an external control sub-system. The system is designed to electrically stimulate the Sphenopalatine Ganglion (SPG) which leads to an increase in blood flow to the anterior circulation of the brain.

  This Pivotal Study is a randomized control study aimed to prove the efficacy of the treatment as a therapy for acute ischemic stroke patients.

  Inclusion Criteria:

  1. Age: Between 40 years and 80 years for male and 85 for female subjects
  2. Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior Cerebral Artery territories
  3. Imaging findings demonstrating signs of ischemia in the anterior circulation, consistent with the clinical diagnosis
  4. Ability to initiate treatment within 8- 24 hours from stroke onset
  5. Ability to Sign an informed consent from by the patient him/herself or by legally authorized representative if applicable

  Exclusion Criteria:
  1. Intracranial hemorrhage or hemorrhagic transformation (Stroke that involves bleeding)
  2. Patients treated with clot removal drugs (IV-tPA ,IA-tPA) or neurothrombectomy devices for the current stroke.
  3.Other exclusion criteria as defined in the trial protocol.

  Final eligibility will be determined by an authorized investigator.

  Eligible patients will be randomized to either Treatment or Sham group. Patients will than receive implantation of the neurostimulator or a sham procedure (puncture of the oral mucosa overlying the implantation site without implantation of the device) be treated or sham treated for 5 consecutive days and followed up for 90 days from stroke onset.

  The trial is being conducted in hospitals with acute stroke units.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  15/WM/0333

• Date of REC Opinion

  16 Nov 2015

• REC opinion

  Further Information Favourable Opinion