Status:
TERMINATED
IMPACT- 24Bt Post Mech. Thrombectomy and/or rtPA TRIAL IMPlant Augmenting Cerebral Blood Flow 24 Hours From Stroke Onset
Lead Sponsor:
BrainsGate
Conditions:
Ischemic Stroke
Eligibility:
All Genders
40-85 years
Phase:
PHASE3
Brief Summary
The primary objective of the study is to assess the safety and effectiveness of SPG stimulation with the ISS in a 24 hour window, in patients with an acute ischemic stroke in the anterior circulation,...
Detailed Description
This will be 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. ...
Eligibility Criteria
Inclusion
- Age: ≥ 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 based on general physical examination and neurological examination.
- Imaging findings demonstrating signs of ischemia (or total arterial occlusion prior to the MT procedure) in the anterior circulation, consistent with the clinical diagnosis.
- Performance of MT within \<8 hours from stroke onset and/or administration of IV-rtPA within ≤ 4.5 hours from stroke onset.
- NIHSS ≥ 7 and ≤ 18 within 2 hours prior to implantation.
- Ability to initiate treatment within
- ≤ 24 hours from stroke onset.
- Signed informed consent from patient him/herself or legally authorized representative if applicable.
Exclusion
- Neuro-imaging evidence of any intracranial hemorrhage (including suspect of Sub Arachnoid Hemorrhage) or hemorrhagic transformation of brain infarct or other significant abnormality (e.g. tumor, abscess)
- Massive stroke, defined as acute parenchymal lesion with effacement of cerebral sulci in over 2/3 of the MCA territory.
- Acute stroke due to lacunar infarct as defined by a clinical syndrome (pure motor hemiparesis, ataxic hemiparesis, sensorimotor stroke, dysarthria-clumsy hand syndrome), unless brain imaging demonstrates a relevant lesion \> 1.5 cm in size.
- 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.
- Minor stroke with non-disabling deficit or rapidly improving neurological symptoms.
- Clinical signs and symptoms or imaging evidence of bilateral stroke.
- Treated with IA-rtPA for the current stroke.
- Complicated MT procedure (including procedures with more than 3 clot removal attempts (catheter passes), or MT procedure that lasted more than 2 hours)
- NIHSS level of consciousness score ≥ 2.
- Previous stroke in the last 6 months or previous stroke with existing sequelae or with mRS \> 0 for any reason
- Pre-existing disability; Pre-existing Modified Rankin Score \>1, even if not stroke-related.
- Patients with bleeding propensity and/or one of the following: INR≥ 1.8, prolonged activated partial thromboplastin time (aPTT) ≥ 45 sec., platelets count \< 75×109/L prior to the implantation/sham procedure.
- Known cerebral arteriovenous malformation, cerebral aneurysm.
- Seizure at onset.
- Blood glucose concentration \< 60 mg/dL.
- Clinical suspicion of septic embolus.
- Uncontrolled hypertension (systolic \>185 mmHg and/or diastolic \>110 mmHg), demonstrated on each of three repeated measurements taken within one hour regardless of whether or not the patient is taking antihypertensive medications.
- 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, etc.).
- History of SPG ablation ipsilateral to the stroke side.
- Any condition in the oral cavity that prevents implantation of the INS, such as patient is intubated, orthodontics or non-hygienic condition.
- Life expectancy \< 1 year from causes other than stroke.
- Participating in any other therapeutic investigational trial within the last 30 days.
- Known sensitivity to any medication 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 :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01874093
Start Date
May 1 2013
End Date
June 1 2018
Last Update
June 26 2018
Active Locations (1)
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1
Vall d'Hebron
Barcelona, Spain, 08035