Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2025-12-25 @ 1:25 PM
Study NCT ID:
NCT00826059
Status:
COMPLETED
Last Update Posted:
2020-02-24
First Post:
2009-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window
Sponsor:
BrainsGate
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double Blind, Sham Control, Parallel Arm Trial to Assess Effectiveness and Safety of the Ischemic Stroke System ISS, as an Adjunct to Standard of Care in Subjects With Acute Ischemic Stroke
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ImpACT-24B
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: