Status:
TERMINATED
IMPACT- 24col Collateral Blood Flow Assessment Following SPG Stimulation in Acute Ischemic Stroke (ImpACT-24B Sub-Study)
Lead Sponsor:
BrainsGate
Conditions:
Ischemic Stroke
Eligibility:
All Genders
40-85 years
Brief Summary
The purpose of the ImpACT-24col sub-study is to explore effect of SPG stimulation on the augmentation of collateral blood flow and to relate it to the subject's cerebral blood flow status, the extent ...
Detailed Description
Stroke is a leading cause of disability, death and health care expenditure. It is the second most common cause of death worldwide, exceeded only by heart disease. Ischemic stroke constitutes 83 to 90%...
Eligibility Criteria
Inclusion
- The Inclusion/Exclusion criteria are those of the ImpACT-24B trial (CLP1000500).
- Additionally, subjects will be excluded from the ImpACT-24col sub-study if DSA is contraindicated (such as allergy to the contract media, etc.).
- Age: Between 40 years and 80 years for male and 85 for female subjects
- Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior Cerebral Artery territories
- Imaging findings demonstrating signs of ischemia in the anterior circulation, consistent with the clinical diagnosis
- Baseline NIHSS ≥ 7 and ≤ 18 within 2 hours prior to implantation.
- Ability to initiate treatment within 8- 24 hours from stroke onset
- Signed informed consent from patient him/herself or legally authorized representative if applicable
Exclusion
- Intracranial hemorrhage or hemorrhagic transformation
- Massive stroke
- Acute ischemic stroke in the posterior circulation
- Minor stroke
- Treated with IV-tPA ,IA-tPA or neurothrombectomy devices for the current stroke
- Previous stroke in the last 6 months or pre-existing disability
- Patients with bleeding propensity or any condition in the oral cavity that prevents implantation
- Clinical signs and symptoms or imaging evidence of bilateral stroke.
- Treated with IV-tPA ,IA-tPA or neurothrombectomy devices for the current stroke.
- Known cerebral arteriovenous malformation, cerebral aneurysm.
- Clinical suspicion of septic embolus.
- Uncontrolled hypertension (systolic \>185 mmHg and/or diastolic \>110 mmHg)
- Serious systemic infection.
- Women known to be pregnant or having a positive or indeterminate pregnancy test.
- Patients with other implanted neural stimulator/ electronic devices (pacemakers).
- Life expectancy \< 1 year from causes other than stroke.
Key Trial Info
Start Date :
September 25 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 3 2018
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03396419
Start Date
September 25 2017
End Date
June 3 2018
Last Update
April 24 2019
Active Locations (1)
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1
High Technology Medical Center University Clinic LTD.
Tbilisi, Georgia, 0144