Status:
UNKNOWN
Augmenting Cerebral Blood Flow to Preserve the Penumbra Trial
Lead Sponsor:
BrainsGate
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The primary objective of the study is to demonstrate that SPG (Sphenopalatine Ganglion) stimulation started within 6 hours from stroke onset slows the expansion of the infarct core volume in acute isc...
Detailed Description
The goal of this study is to identify Acute Ischemic Stroke patients who have a potentially salvageable penumbra and to test if 6 hours of SPG (Sphenopalatine Ganglion) stimulation may "freeze" the vo...
Eligibility Criteria
Inclusion
- Signs \& symptoms consistent with the diagnosis of large vessel occlusion in the anterior circulation
- Age 18-90 years
- Baseline NIHSS ≥ 10
- Ability to initiate treatment within 6 hours from stroke onset. Stroke onset is defined as the time the patient was last seen well.
- Large vessel total occlusion by CTA
- Penumbra ≥ 50ml (Difference between Tmax6 volume and the ischemic core volume (CBF\<38% volume)
- Mismatch (Tmax6 volume/ischemic core volume (CBF\<38% volume) ≥1.5
- Core and HIR (Tmax10 / Tmax6) volumes: 1. HIR ≥ 0.5 or 2. 0.35 ≤ HIR \< 0.5 and "core volume/time from onset to imaging" ≥ 7mililiter/hour
- Signed informed consent from patient him/herself or legally authorized representative.
Exclusion
- Unable to undergo a contrast brain perfusion scan, including an allergy to contrast media
- Opportunity for reperfusion therapy (IV thrombolysis or endovascular treatment)
- Neuro-imaging evidence of any intracranial hemorrhage or hemorrhagic transformation of brain infarct or other significant abnormality (e.g. tumor, abscess, suspect for subarachnoid hemorrhage, arteriovenous malformation, cerebral aneurysm).
- Significant mass effect with midline shift.
- Infarct core volume \>150 milliliter
- Old non-lacunar infarct in the anterior circulation on the ipsilateral hemisphere.
- Previous stroke in the last 6 months or previous stroke with existing sequelae or with mRS \> 0 for any reason
- Pre-existing Modified Rankin Score \>1, even if not stroke-related.
- Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion).
- Seizures at stroke onset
- Baseline blood glucose of \<50mg/dL (2.78 mmol) or \>400mg/dL (22.20 mmol)
- Severe, sustained hypertension (Systolic BP \>185 mmHg or Diastolic BP \>110 mmHg)
- Current participation in another investigational drug or device study
- Presumed septic embolus; suspicion of bacterial endocarditis
- Clinical signs and symptoms or evidence for a relevant lesion by neuro-imaging of an acute ischemic stroke in the posterior circulation (Vertebral, Basilar and/or Posterior Cerebral Artery territories), including but not limited to brain-stem findings and/or cerebellar findings and/or isolated homonymous hemianopia or cortical blindness.
- Patients with bleeding propensity and/or one of the following: INR \> 1.8, prolonged activated partial thromboplastin time (aPTT) ≥ 45 sec., platelets count \< 75×10\^9/L.
- 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).
- History of SPG ablation ipsilateral to the stroke side.
- Any condition in the oral cavity that prevents implantation of the INS.
- Known sensitivity to any medications to be used during study.
- Subjects who have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Conditions may include: cardiovascular, vascular, pulmonary, hepatic, renal or neurological (other than acute ischemic stroke), or neoplastic diseases, as determined by medical history, physical examination, laboratory tests, or ECG.
- Subjects who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study.
Key Trial Info
Start Date :
October 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04014621
Start Date
October 20 2019
End Date
April 1 2021
Last Update
October 30 2019
Active Locations (4)
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1
Academian Z.Tskhakaia West Georgia National Center of Interventional Medicine
Kutaisi, Georgia
2
Rustavi Central Hospital
Rustavi, Georgia
3
K. Eristavi National center of clinical and experimental surgery's hospital "New Life"
Tbilisi, Georgia
4
LTD High Technology Medical Center University Clinic
Tbilisi, Georgia