Stroke, Ischemic
Conditions
Keywords
Mechanical thrombectomy, Acute ischemic stroke, neurovascular intervention
Brief summary
The purpose of this study is to collect real-world safety and performance data on the MIVI Neuroscience, Inc. Q Aspiration Catheter for use in the removal of fresh, soft emboli and thrombi in the neurovascular system during acute ischemic stroke.
Detailed description
The purpose of this study is to demonstrate the safety and performance of the MIVI Neuroscience, Inc. CE Marked Q Aspiration Catheter for use in the removal of fresh, soft emboli and thrombi in the neurovascular system during acute ischemic stroke. The study is an observational study collecting Q Aspiration Catheter use that will enroll a maximum of 50 subjects at a maximum of 5 sites in Spain. Subjects data will be collected through hospitalization with a 3 months post-procedure study visit. This study is designed for observational data to be collected and reported.
Interventions
DEVICEQ Aspiration Catheter
The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in the neurovascular system.
Sponsors
MIVI Neuroscience, Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 85 years; * Diagnosis of acute ischemic stroke with mechanical thrombectomy procedure \< 8 hours from onset of symptoms/ last known well; * Large Vessel Occlusion on CT or MRI in the anterior cerebral vasculature up to A1, M1, or M2 or the posterior cerebral vasculature; * ASPECTS 6 - 10 or volume of diffusion restriction \< 50 mL; * Use of the Q Aspiration Catheter as the first line treatment according to the IFU; * Signed informed consent by patient or legally authorized representative.
Exclusion criteria
* Occlusions in multiple vascular territories, extracranial occlusion or tandem occlusion; * Evidence of dissection in the carotid or target artery for treatment; * Evidence of recent/fresh haemorrhage on presentation; * Unwilling to agree to a 3-month follow up visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic Intracranial Haemorrhage Rate | 24 hours post procedure | Defined as the symptomatic intracranial haemorrhage as detected by CT/MRI with an NIHSS change of \>/= 4 points |
| Successful Revascularization Rate | intra-procedural | Defined as final modified Thrombolysis In Cerebral Infarction scale (mTICI 2b-3) flow in the target vessel |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful Revascularization Rate Using the Q Aspiration Catheter as the Only Thrombectomy Device | intra-procedural | Defined as mTICI 2b-3 flow in the target vessel post-treatment with the Q Catheter (first line therapy) |
| Rate of Embolization to a New Neurovascular Territory (ENT) | intra-procedural | As measured by independent Angiographic Core Lab |
| Good Functional Outcome Measured by Modified Rankin Scale Score of 0-2 | 90 days | The Modified Rankin Scale (mRS) measures neurological disability or dependence for stroke patients on a scale of 0 (no symptoms) to 6 (deceased). |
| Mortality Rate | 90 days | Rate of all cause mortality |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Q Aspiration Catheter mechanical thrombectomy for acute ischemic stroke
Q Aspiration Catheter: The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in the neurovascular system. | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | Q Aspiration Catheter | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 38 Participants | — |
| Age, Categorical Between 18 and 65 years | 7 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Spain | 45 Participants | — |
| Sex: Female, Male Female | 21 Participants | — |
| Sex: Female, Male Male | 24 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 45 |
| other Total, other adverse events | 6 / 45 |
| serious Total, serious adverse events | 11 / 45 |
Outcome results
Primary
Successful Revascularization Rate
Defined as final modified Thrombolysis In Cerebral Infarction scale (mTICI 2b-3) flow in the target vessel
Time frame: intra-procedural
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Q Aspiration Catheter | Successful Revascularization Rate | 42 Participants |
Primary
Symptomatic Intracranial Haemorrhage Rate
Defined as the symptomatic intracranial haemorrhage as detected by CT/MRI with an NIHSS change of \>/= 4 points
Time frame: 24 hours post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Q Aspiration Catheter | Symptomatic Intracranial Haemorrhage Rate | 1 Participants |
Secondary
Good Functional Outcome Measured by Modified Rankin Scale Score of 0-2
The Modified Rankin Scale (mRS) measures neurological disability or dependence for stroke patients on a scale of 0 (no symptoms) to 6 (deceased).
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Q Aspiration Catheter | Good Functional Outcome Measured by Modified Rankin Scale Score of 0-2 | 25 Participants |
Secondary
Mortality Rate
Rate of all cause mortality
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Q Aspiration Catheter | Mortality Rate | 7 Participants |
Secondary
Rate of Embolization to a New Neurovascular Territory (ENT)
As measured by independent Angiographic Core Lab
Time frame: intra-procedural
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Q Aspiration Catheter | Rate of Embolization to a New Neurovascular Territory (ENT) | 0 Participants |
Secondary
Successful Revascularization Rate Using the Q Aspiration Catheter as the Only Thrombectomy Device
Defined as mTICI 2b-3 flow in the target vessel post-treatment with the Q Catheter (first line therapy)
Time frame: intra-procedural
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Q Aspiration Catheter | Successful Revascularization Rate Using the Q Aspiration Catheter as the Only Thrombectomy Device | 25 Participants |