Ischemic Stroke
Conditions
Keywords
Stroke, Ischemic, Thrombus, Embolectomy, Thrombectomy, Concentric, Embolus, Mechanical, Trevo
Brief summary
To determine the revascularization rate of the CE-marked Trevo device in large vessel occlusions in ischemic stroke patients. * Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure.
Detailed description
* Clinical outcomes at 90 days * Mortality at 90 days * Device-related serious adverse events (DRSAEs) * Symptomatic ICH rate within 24 (-6/+12) hours post-procedure
Interventions
PROCEDUREMechanical Thrombectomy
The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
Sponsors
Stryker Neurovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-79 (has had 18th birthday, but not yet had 80th birthday) * NIHSS 8 - 30 * Anticipated life expectancy of at least 6 months * No significant pre-stroke disability (mRS less than or equal to 1) * Written informed consent to participate given by patient or legal representative * Angiographic confirmation of a persistent large vessel occlusion, in the internal carotid, middle cerebral M1 and/or M2 segments, basilar or vertebral arteries * Treatable within 8 hours of symptom onset, defined as the first pass being made with the Trevo device.
Exclusion criteria
* Baseline glucose of \< 50 mg/dL (2.78 mmol) or \> 400 mg / dL (22.20 mmol) * Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0 * Treated with Heparin within 48 hours with a PTT greater than 2 times the lab normal * Baseline platelet count \< 30,000 * History of severe allergy (more than rash) to contrast medium * Severe, sustained hypertension (SBP \> 185 mm Hg or DBP \> 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using medication (i.e. Nipride), the patient can be enrolled * Woman of child bearing potential who is known to be pregnant * Patient participating in another clinical study or protocol * For anterior circulation strokes: strokes involving greater than 1/3 of the MCA territory, as determined by hypodensity on the baseline non- contrast CT, or low CBV on CT Perfusion imaging, or restricted diffusion on DWI images * For posterior circulation strokes within the midbrain and/or pons, extensive hypodensity on the baseline CT, or low CBV on CT Perfusion imaging, or extensive restricted diffusion on DWI images * Baseline CT/MR evidence of significant mass effect with midline shift * Baseline CT/MR evidence of hemorrhage * Baseline CT/MR evidence of intracranial tumor (except small meningioma) * Angiographic evidence of vasculitis or arterial dissection * High grade stenosis that cannot be treated safely or which prevents access to the thrombus with the Trevo device * Angiographic evidence of excessive arterial tortuosity that precludes the Trevo device from reaching the thrombus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revascularization Status | Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment | Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure Thrombolysis in Cerebral Infarction (TICI) grading system for perfusion (ie blood flow through a vessel) Grade 0:No Perfusion. No antegrade flow beyond the point of occlusion. Grade 1:Penetration With Minimal Perfusion. Grade 2:Partial Perfusion. Grade 2a:Only partial filling (\<2/3) of the entire vascular territory is visualized. Grade 2b:Complete filling of all of the expected vascular territory is visualized, but slower ... Grade 3:Complete Perfusion. For complete info see Higashida RT, Furlan AJ, Roberts H, Tomsick T, Connors B et al. (2003) Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke. Stroke 34: e109-e137.10.1161/01.STR.0000082721.62796.09 PubMed: 12869717\[PubMed\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcomes at 90 Days | 90-day | Good clinical outcome is defined as an modified Rankin Scale (mRS) score of 0-2 at 90 days. mRS 0-2 indicates functional independence 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. https://en.wikipedia.org/wiki/Modified\_Rankin\_Scale |
| Mortality at 90 Days | 90-day | All cause mortality through 90 days post procedure. |
Countries
Austria, Germany, Spain, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acute Ischemic Stroke Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke
Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Acute Ischemic Stroke |
|---|---|
| Age, Continuous | 64.7 years STANDARD_DEVIATION 13.4 |
| NIHSS | 17.7 units on a scale STANDARD_DEVIATION 4.8 |
| Region of Enrollment Austria | 16 participants |
| Region of Enrollment Germany | 19 participants |
| Region of Enrollment Spain | 22 participants |
| Region of Enrollment Sweden | 3 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 60 |
| serious Total, serious adverse events | 12 / 60 |
Outcome results
Primary
Revascularization Status
Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure Thrombolysis in Cerebral Infarction (TICI) grading system for perfusion (ie blood flow through a vessel) Grade 0:No Perfusion. No antegrade flow beyond the point of occlusion. Grade 1:Penetration With Minimal Perfusion. Grade 2:Partial Perfusion. Grade 2a:Only partial filling (\<2/3) of the entire vascular territory is visualized. Grade 2b:Complete filling of all of the expected vascular territory is visualized, but slower ... Grade 3:Complete Perfusion. For complete info see Higashida RT, Furlan AJ, Roberts H, Tomsick T, Connors B et al. (2003) Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke. Stroke 34: e109-e137.10.1161/01.STR.0000082721.62796.09 PubMed: 12869717\[PubMed\]
Time frame: Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acute Ischemic Stroke | Revascularization Status | 92 percentage of subjects TICI 2 or > |
Secondary
Clinical Outcomes at 90 Days
Good clinical outcome is defined as an modified Rankin Scale (mRS) score of 0-2 at 90 days. mRS 0-2 indicates functional independence 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. https://en.wikipedia.org/wiki/Modified\_Rankin\_Scale
Time frame: 90-day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acute Ischemic Stroke | Clinical Outcomes at 90 Days | 55 percentage of subjects with mrs 0-2 |
Secondary
Mortality at 90 Days
All cause mortality through 90 days post procedure.
Time frame: 90-day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acute Ischemic Stroke | Mortality at 90 Days | 12 participants |