Acute ischemic stroke
Conditions
Interventions
Group 1: Within the scope of this study, the investigator collects medical data from the patients, e.g. information on age, gender, medical history and course of the disease, current condition, perfor
Sponsors
ThrombX Medical, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: - Age 18 to 85; - Clinical signs consistent with acute anterior circulation ischemic stroke; - Pre-stroke Modified Rankin Score = 2; - NIHSS = 4 and < 25 immediately prior to enrollment; - Imaging shows Alberta Stroke Program early computed tomography (ASPECT) score =6 with computed tomography (CT) scanning or core infarct volume <50mL on magnetic resonance imaging (MRI) or CT based perfusion imaging; - Computed tomographic angiography (CTA) or magnetic resonance angiography (MRA) shows an occlusion of the intracranial carotid or the middle cerebral artery M1 division; - An appropriate signed and dated informed consent form is obtained from the patient or the patient’s legally designated representative and treating physician
Exclusion criteria
Exclusion criteria: - Known serious sensitivity to radiographic contrast agents; - Known sensitivity to nickel, titanium metals, or their alloys: - Renal failure as defined by a serum creatinine > 2·0 mg/dl (or 176·8 µmol/l) or glomerular filtration rate (GFR) 400mg/dL (22.20 mmol); - Baseline platelet count < 50,000/uL; - Presumed septic embolus; suspicion of bacterial endocarditis; - Contraindication to an angiogram for any reason; - Known history of arterial tortuosity, preexisting stent, or other arterial disease that would prevent the device from reaching the target vessel or preclude safe recovery of the device; - Presence of carotid dissection; - Imaging or clinical evidence of concomitant posterior circulation stroke or acute stroke involving both anterior circulations; - CT or MRI evidence of hemorrhage or evidence of mass effect; - Imaging evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target lesion, moderate/large infarct with poor collateral circulation)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified TICI score as determined by the immediate post-procedure angiogram after three or fewer passes with the device | — |
Secondary
| Measure | Time frame |
|---|---|
| - Rate of first pass TICI 2C to 3 reperfusion - Functional independence, defined as an mRS score < 2 at 90 days | — |
Countries
Germany, Hungary
Contacts
Public ContactMichale Marks
ThrombX Medical, Inc.
Outcome results
None listed