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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Q Aspiration Catheter | mechanical thrombectomy for acute ischemic stroke |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Q Aspiration Catheter | Device | The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in the neurovascular system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful Revascularization Rate | Defined as final modified Thrombolysis In Cerebral Infarction scale (mTICI 2b-3) flow in the target vessel | intra-procedural |
| Symptomatic Intracranial Haemorrhage Rate | Defined as the symptomatic intracranial haemorrhage as detected by CT/MRI with an NIHSS change of >/= 4 points | 24 hours post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | intra-procedural |
| Rate of Embolization to a New Neurovascular Territory (ENT) |
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Inclusion Criteria:
Exclusion Criteria:
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Population is patients diagnosed with large vessel occlusion acute ischemic stroke within 8 hours of stroke onset treated with mechanical aspiration thrombectomy with the Q Aspiration Catheter as first line therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Mariano Espinosa de Rueda Ruiz, MD | Neurorradiologia Intervencionista, HCUVA, Murcia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario 12 De Octubre | Madrid | Spain | ||||
| Hospital Virgen de la Arrixaca |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35641183 | Result | Espinosa de Rueda M, Ballenilla Marco F, Garmendia Lopetegui E, Pumar JM, Zamarro J, Garcia-Villalba B, Diaz-Perez J, Mosqueira A, Luttich A, Larrea JA, Parrilla G. Thrombectomy aspiration post-market study in acute stroke with the Q aspiration catheter: the TAPAS study. J Neurointerv Surg. 2023 Jul;15(7):674-678. doi: 10.1136/neurintsurg-2022-018649. Epub 2022 May 31. |
| Label | URL |
|---|---|
| Thrombectomy aspiration post-market study in acute stroke with the Q aspiration catheter: the TAPAS study | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Successful Revascularization Rate | Defined as final modified Thrombolysis In Cerebral Infarction scale (mTICI 2b-3) flow in the target vessel | Posted | Count of Participants | Participants | intra-procedural |
|
|
From procedure through subject 3 month follow up visit, serious adverse events were collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrhagic transformation | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| procedural complication | Injury, poisoning and procedural complications | Non-systematic Assessment | vasospasm, vessel dissection, and/or access site complication |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mariano Espinosa de Rueda | Department of Interventional Neuroradiology, Hospital ClÃnico Universitario Virgen de la Arrixaca, Murcia, Spain | +34 968 36 96 42 | mm.espinosa@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2019 | Oct 28, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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As measured by independent Angiographic Core Lab |
| intra-procedural |
| 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). | 90 days |
| Mortality Rate | Rate of all cause mortality | 90 days |
| Murcia |
| Spain |
| Centro Hospitalario Universitario Donostia | San Sebastián | Spain |
| Hospital Universitario de Santiago de Compostela | Santiago de Compostela | Spain |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Primary | Symptomatic Intracranial Haemorrhage Rate | Defined as the symptomatic intracranial haemorrhage as detected by CT/MRI with an NIHSS change of >/= 4 points | Posted | Count of Participants | Participants | 24 hours post procedure |
|
|
|
| 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) | Posted | Count of Participants | Participants | intra-procedural |
|
|
|
| Secondary | Rate of Embolization to a New Neurovascular Territory (ENT) | As measured by independent Angiographic Core Lab | Posted | Count of Participants | Participants | intra-procedural |
|
|
|
| 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). | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Mortality Rate | Rate of all cause mortality | Posted | Count of Participants | Participants | 90 days |
|
|
|
| 7 |
| 45 |
| 11 |
| 45 |
| 6 |
| 45 |
| Death of unknown cause | General disorders | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| mechanical ventilation complications | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
|
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| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |