Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window (ImpACT-24)
|Ischemic Stroke||Device: The Ischemic Stroke System Device: Sham control||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Distribution of patients across the ordinal modified Rankin scale (mRS) [ Time Frame: 90 days ]
The primary effectiveness endpoint will be the modified Rankin Scale (mRS) evaluated by the site on Day 90±7.
The statistical analysis of the primary effectiveness endpoint will be: Sliding Dichotomous mRS.
- Sliding Dichotomous mRS for subjects with aphasia at baseline [ Time Frame: 90 days ]
- Binary NIHSS (success for score ≤ 1 or for ≥ 9-point improvement versus baseline) [ Time Frame: 90 days ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||January 2018 (Final data collection date for primary outcome measure)|
Experimental: Active Stimulation
Implantation and ISS Stimulation during five consecutive days & Standard of Care
Device: The Ischemic Stroke System
SPG stimulation and standard of care
Sham Comparator: Sham Stimulation
Sham Implantation and Sham Stimulation during five consecutive days & Standard of Care
Device: Sham control
Sham stimulation and standard of care
A multi-center, multinational, randomized, double blind, sham control, adjunctive to Standard of Care, parallel arm study and will include ongoing DSMB review of accumulated safety data.
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 in a 1:1 (ISS Stimulation: Sham Control) ratio:
- 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.
Following implantation, stimulation/sham stimulation will be delivered. Day 2-4 ISS / Sham Stimulation will be repeated during the following four consecutive days by trained personnel within 18-26 hours from preceding stimulation.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00826059
|Contact: Michael Segev||+972 4 637 7774 ext firstname.lastname@example.org|
|Contact: Noam Levy||+972 4 637 7774 ext email@example.com|
|United States, Florida|
|Intercoastal Medical Group||Recruiting|
|Sarasota, Florida, United States, 34232|
|United States, Illinois|
|Central DuPage Hospital||Recruiting|
|Winfield, Illinois, United States, 60190|
|United States, Massachusetts|
|UMASS Medical Center||Withdrawn|
|Worcester, Massachusetts, United States, 01655|
|United States, North Carolina|
|Guilford Neurologic Associates||Recruiting|
|Greensboro, North Carolina, United States, 27401|
|United States, Ohio|
|ProMedica Toledo Hospital||Recruiting|
|Toledo, Ohio, United States, 43606|
|United States, South Carolina|
|Palmetto Health Richland||Recruiting|
|Columbia, South Carolina, United States, 29203|
|United States, Tennessee|
|Erlanger Stroke Center||Recruiting|
|Chattanooga, Tennessee, United States, 37404|
|Erlangen University Clinic||Recruiting|
|Essen University Clinic||Recruiting|
|Heidelberg University Clinic||Recruiting|
|Leipzig University Clinic||Recruiting|
|Hospital Vall d'Hebron||Recruiting|
|Study Director:||Eyal Shay||BrainsGate|