Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window (ImpACT-24)
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|ClinicalTrials.gov Identifier: NCT00826059|
Recruitment Status : Completed
First Posted : January 21, 2009
Last Update Posted : June 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke||Device: The Ischemic Stroke System Device: Sham control||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||June 2018|
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
- 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 primary effectiveness endpoint will be assessed on the Primary Effectiveness Analysis set and on the Responders subgroup.
The Responders subgroup: baseline NIHSS ≥ 10 and signs of cortical involvement in baseline imaging (at least one of the following ASPECT regions: M1-M6, Insular Cortex).
Type I Error will be controlled at an overall level of 0.05 (two-sided) using the Hochberg method.
- Primary and secondary endpoints by subgroup analysis [ Time Frame: 90 days ]Primary and secondary endpoints by subgroup analysis of: NIHSS strata
- Primary and secondary endpoints by subgroup analysis [ Time Frame: 90 days ]Primary and secondary endpoints by subgroup analysis of: lesion size
- Primary and secondary endpoints by subgroup analysis [ Time Frame: 90 days ]Primary and secondary endpoints by subgroup analysis of: time from stroke onset strata
- Primary and secondary endpoints by subgroup analysis [ Time Frame: 90 days ]Primary and secondary endpoints by subgroup analysis of: gender
- Primary and secondary endpoints by subgroup analysis [ Time Frame: 90 days ]Primary and secondary endpoints by subgroup analysis of: side
- Primary and secondary endpoints by subgroup analysis [ Time Frame: 90 days ]Primary and secondary endpoints by subgroup analysis of: stroke area.
- SIS-16 [ Time Frame: 90 days ]SIS-16
- Risk- Stroke assessment [ Time Frame: 180 days and 360 days ]RIKS- Stroke assessment at 180±7 and 360±7 days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00826059
|United States, Florida|
|Intercoastal Medical Group|
|Sarasota, Florida, United States, 34232|
|United States, Illinois|
|Central DuPage Hospital|
|Winfield, Illinois, United States, 60190|
|United States, North Carolina|
|Guilford Neurologic Associates|
|Greensboro, North Carolina, United States, 27401|
|United States, Ohio|
|ProMedica Toledo Hospital|
|Toledo, Ohio, United States, 43606|
|United States, South Carolina|
|Palmetto Health Richland|
|Columbia, South Carolina, United States, 29203|
|United States, Tennessee|
|Erlanger Stroke Center|
|Chattanooga, Tennessee, United States, 37404|
|Rustavi Central Hospital|
|Rustavi, Georgia, 3700|
|First University Clinic|
|Tbilisi, Georgia, 0141|
|High Technology Medical Center University Clinic LTD.|
|Tbilisi, Georgia, 0144|
|Zugdidi Referral Hospital|
|Zugdidi, Georgia, 2100|
|Erlangen University Clinic|
|Essen University Clinic|
|Heidelberg University Clinic|
|Leipzig University Clinic|
|Hospital Vall d'Hebron|
|Study Director:||Eyal Shay||BrainsGate|