Ischemic Stroke
Conditions
Keywords
Cerebral Infarction, Stroke, Vascular Diseases, Central Nervous System Diseases, Penumbra, Functional Outcome, Aphasia, Hemiplegia, Left sided weakness, Right Sided weakness
Brief summary
The primary study objective is to assess the feasibility of using the MindFrame System to safely and effectively restore blood flow in a thrombotic neurovascular occlusion in patients experiencing an ischemic stroke.
Detailed description
The objective of PRIISM is to assess the feasibility of using the MindFrame System to safely and effectively restore blood flow in a thrombotic neurovascular occlusion in patients with acute ischemic stroke. Safety will be assessed by the device-related serious event rate as it compares to other similar therapies. The events include but are not limited to symptomatic hemorrhage, vessel dissection, embolization and overall morbidity and mortality. Target vessels include the basilar, internal carotid and middle cerebral (M1 and M2 segments) arteries.
Interventions
DEVICEMindFrame System
Thrombectomy Catheter designed to rapidly restore blood flow in patients experiencing an ischemic stroke
Sponsors
MindFrame, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. NIHSS 6 to 30 within 6 hours of symptom onset 2. Pre-stroke Modified Rankin Score ≤ 2 3. Large Vessel Occlusion 4. Patient/patient guardian is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluation. 5. Patients must meet at least one of the following criteria: * Eligible for Intravenous rt-PA * Eligible for Intra-arterial rt-PA - IA rt-PA initiated within 6 hours of symptom onset * Patient presents within 6 hours of symptom onset
Exclusion criteria
1. Pregnancy 2. Glucose \<50mg/dL 3. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR\>3.0 4. Patient received heparin within 48 hours with a PTT greater than 2 times the lab normal. 5. Patient has baseline platelets \< 30,000 6. Evidence of rapidly improving neurological signs of stroke at time of enrollment 7. Coma 8. Pre-existing neurological or psychiatric disease that could confound the study results 9. Known severe allergy to contrast media or nitinol 10. Patient has severe sustained hypertension 11. CT/MRI scan reveals significant mass effect with midline shift 12. Patient's angiogram shows an arterial stenosis \>50% proximal to the embolus. 13. Patient's anticipated life expectancy is less than 3 months 14. Participation in another clinical investigation that could confound the evaluation of the study device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Device Success by as Assessed by the Percentage of Participants Which Established at Least TIMI 2 Flow Upon Deployment of the System Across the Occlusion and Within 30 Minutes of Placing the Guide Catheter. | Immediately postprocedure | TIMI Flow is a perfusion scoring system from 0-3 referring to levels of blood flow assessed during reperfusion procedures: TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow |
| Procedural Success as Determined by the Overal Percentage of Patients Who Achieve TIMI Grade 2/3 Flow, With or Without the Use of Adjuvant Therapy, in All Treatable Vessels as Confirmed by the Final Post Treatment Angiogram. | Immediately postprocedure | TIMI Flow is a scoring system from 0-3 referring to levels of blood flow assessed during percutaneous coronary angioplasty: TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow |
| Clinical Success | 90 days postprocedure | Clinical Success as determined by achievment of a Modified Rankin Scale score of 0-2 at 90 days postprocedure. The modified Rankin Scale is a measure of a patient's level of functional independence with 0=normal and 6-death. Patients with a score of 0-2 are considered functionally independent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Device-related Serious Adverse Events | Treatment to 90 days postprocedure | Evaluation of the safety of using the MindFrame System based on device-related serious adverse event(s). Device-related serious adverse events are defined as vessel perforation, intramural arterial dissection, device-related symptomatic intracranial hemorrhage, and significant embolization in a previously uninvolved arterial territory. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group All participants treated with the Test System | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Treatment Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 24 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age Continuous | 63.8 years STANDARD_DEVIATION 13.6 |
| Mean Baseline National Institutes of Health Stroke Scale (NIHSS) score | 16.5 NIHSS units STANDARD_DEVIATION 4.7 |
| Median Baseline NIHSS score | 16 NIHSS units |
| Region of Enrollment Germany | 14 participants |
| Region of Enrollment Poland | 3 participants |
| Region of Enrollment Sweden | 23 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 40 |
| serious Total, serious adverse events | 14 / 40 |
Outcome results
Primary
Clinical Success
Clinical Success as determined by achievment of a Modified Rankin Scale score of 0-2 at 90 days postprocedure. The modified Rankin Scale is a measure of a patient's level of functional independence with 0=normal and 6-death. Patients with a score of 0-2 are considered functionally independent.
Time frame: 90 days postprocedure
Population: Percentage of participants achieving a Modified Rankin Scale score of 0-2 at 90 days postprocedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Group | Clinical Success | 47.5 percentage of participants |
Primary
Procedural Success as Determined by the Overal Percentage of Patients Who Achieve TIMI Grade 2/3 Flow, With or Without the Use of Adjuvant Therapy, in All Treatable Vessels as Confirmed by the Final Post Treatment Angiogram.
TIMI Flow is a scoring system from 0-3 referring to levels of blood flow assessed during percutaneous coronary angioplasty: TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow
Time frame: Immediately postprocedure
Population: Percentage of participants who achieved (TIMI/TICI grade 2/3 flow), with or without the use of adjuvant therapy, in all treatable vessels as confirmed by the final post treatment angiogram.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Group | Procedural Success as Determined by the Overal Percentage of Patients Who Achieve TIMI Grade 2/3 Flow, With or Without the Use of Adjuvant Therapy, in All Treatable Vessels as Confirmed by the Final Post Treatment Angiogram. | 82.5 percentage of participants |
Primary
Technical Device Success by as Assessed by the Percentage of Participants Which Established at Least TIMI 2 Flow Upon Deployment of the System Across the Occlusion and Within 30 Minutes of Placing the Guide Catheter.
TIMI Flow is a perfusion scoring system from 0-3 referring to levels of blood flow assessed during reperfusion procedures: TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow
Time frame: Immediately postprocedure
Population: All participants treated with the Test System
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Group | Technical Device Success by as Assessed by the Percentage of Participants Which Established at Least TIMI 2 Flow Upon Deployment of the System Across the Occlusion and Within 30 Minutes of Placing the Guide Catheter. | 75 percentage of participants |
Secondary
Number of Device-related Serious Adverse Events
Evaluation of the safety of using the MindFrame System based on device-related serious adverse event(s). Device-related serious adverse events are defined as vessel perforation, intramural arterial dissection, device-related symptomatic intracranial hemorrhage, and significant embolization in a previously uninvolved arterial territory.
Time frame: Treatment to 90 days postprocedure
Population: Per protocol analysis of all participants treated with the 1st generation MindFrame System of neurothrombotic stent retrievers.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Group | Number of Device-related Serious Adverse Events | 2 events |