Ischemic Stroke
Conditions
Brief summary
This trial is designed to assess the safety and effectiveness of the ThrombX Retriever.
Detailed description
This trial is a clinical evaluation is to assess the safety and effectiveness of the ThrombX Retriever in the revascularization of the site of primary occlusion in patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease.
Interventions
DEVICEMechanical thrombectomy with ThrombX Retriever
Revascularization
Sponsors
ThrombX Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single group assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Acute anterior circulation ischemic stroke * Pre-stroke Modified Rankin Score ≤ 1 * NIHSS ≥ 6 and \< 25 immediately prior to enrollment * ASPECT score ≥6 with CT scanning or core infarct volume \<50 mL on magnetic MRI or CT based perfusion imaging * Occlusion of IC or the middle cerebral artery M1 or M2 division * Subject can be treated within eight-hours of onset of stroke symptoms
Exclusion criteria
* Pregnant or lactating at time of admission * Known serious sensitivity to radiographic contrast agents * Known sensitivity to nickel, titanium metals, or their alloys * Current participation in another investigation drug or device treatment study * Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency prothrombin time lab results to be available prior to enrollment) * Renal failure * Baseline blood glucose of \<50mg/dL (2.78 mmol/L) or \>400mg/dL (22.20 mmol/L) * Baseline platelet count \< 50,000/uL * Severe, sustained hypertension * Presumed septic embolus, suspicion of bacterial endocarditis * Subject has a contraindication to an angiogram * Life expectancy \<6 months * Comorbid disease or condition that would confound assessments * Known history of arterial tortuosity, preexisting stent, and/or other arterial disease * Tandem lesions, occlusion requiring angioplasty and/or stent placement or evidence of carotid dissection * Site of occlusion is heavily calcified * Imaging or clinical evidence of bilateral strokes or concomitant posterior circulation stroke * CT or MRI evidence of hemorrhage or evidence of mass effect or intra-cranial tumor * Imaging evidence suggests subject is not appropriate for mechanical thrombectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful reperfusion of the occluded target vessel with up to 3 passes of the ThrombX Retriever | Up to the end of theprocedure | Defined by a mTICI score \>2b |
| Safety Endpoint | 24 hours | Symptomatic intracerebral hemorrhage (sICH) confirmed on imaging and other Serious Adverse Device Effects (SADE) within 24 hours post procedure. The sICH is defined as the presence of extravascular blood in the cranium associated with an increase in the NIHSS score of ≥ 4 points or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional independence defined by modified Rankin Scale (mRS) | 90 Days | modified Ranking Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death. |
Contacts
Primary ContactClaire Houston, MS
Outcome results
None listed