Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window (ImpACT-24A)
| Status: | Terminated |
|---|---|
| Conditions: | Peripheral Vascular Disease, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 1/30/2019 |
| Start Date: | January 2009 |
| End Date: | March 2012 |
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
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.
stimulation with the ISS in patients with an acute ischemic stroke in the anterior
circulation initiated within 24 hours from stroke onset.
This study was first registered as NCT00826059 on January 19, 2009 under the name ImpACT-24.
Background:
Recruitment to ImpACT-24 was halted, the protocol was amended and then the study was resumed.
Later, it was decided to define the first part (before the halt) as a separate study -
ImpACT-24A, and identify the continuation of the study as ImpACT-24B. ImpACT-24B continues to
be registered as NCT00826059, and ImpACT-24A is registered in this new record.
Detailed Description:
A multi-center, multinational, randomized, double blind, sham control, adjunctive to Standard
of Care, parallel arm study with ongoing DSMB review of accumulated safety data.
Screening:
Treatment should be initiated between 8 and 24 hours from stroke onset. 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 2:1 (ISS Stimulation: Sham Control) ratio:
Group 1: Implantation and ISS Stimulation during five consecutive days & Standard of Care
Group 2: Implantation and Sham Stimulation during five consecutive days & Standard of Care
The implantation will be performed by a trained physician. Stimulation/sham stimulation will
be delivered Day 2-5 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.
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 - 90±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.
Background:
Recruitment to ImpACT-24 was halted, the protocol was amended and then the study was resumed.
Later, it was decided to define the first part (before the halt) as a separate study -
ImpACT-24A, and identify the continuation of the study as ImpACT-24B. ImpACT-24B continues to
be registered as NCT00826059, and ImpACT-24A is registered in this new record.
Detailed Description:
A multi-center, multinational, randomized, double blind, sham control, adjunctive to Standard
of Care, parallel arm study with ongoing DSMB review of accumulated safety data.
Screening:
Treatment should be initiated between 8 and 24 hours from stroke onset. 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 2:1 (ISS Stimulation: Sham Control) ratio:
Group 1: Implantation and ISS Stimulation during five consecutive days & Standard of Care
Group 2: Implantation and Sham Stimulation during five consecutive days & Standard of Care
The implantation will be performed by a trained physician. Stimulation/sham stimulation will
be delivered Day 2-5 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.
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 - 90±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.
Inclusion Criteria:
1. Age: ≥ 18 years and ≤ 85 of both genders.
2. Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior
Cerebral Artery territories
3. Baseline NIHSS ≥ 7 and ≤ 18
4. Ability to initiate treatment within 8- 24 hours from stroke onset.
Exclusion Criteria:
1. Intracranial hemorrhage or hemorrhagic transformation
2. Massive stroke
3. Acute ischemic stroke in the posterior circulation
4. Minor stroke
5. Treated with IV-tPA ,IA-tPA or neurothrombectomy devices for the current stroke
6. Previous stroke in the last 6 months or pre-existing disability
7. Patients with bleeding propensity or any condition in the oral cavity that prevents
implantation
8. Known cerebral arteriovenous malformation, cerebral aneurysm.
9. Clinical suspicion of septic embolus.
10. Uncontrolled hypertension (systolic >185 mmHg and/or diastolic >110 mmHg)
11. Serious systemic infection.
12. Women known to be pregnant or having a positive or indeterminate pregnancy test.
13. Patients with other implanted neural stimulator/ electronic devices (pacemakers).
14. Life expectancy < 1 year from causes other than stroke.
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