Clinical trial NCT04089917: A Study of the Use of the Q Aspiration Catheter to Remove Clot in Stroke Patients
Official title: An Observational Study of the Q Aspiration Catheter Used During Neurointervention for Acute Large Vessel Ischemic Stroke in Spain.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Ischemic
Keywords: Mechanical thrombectomy
Acute ischemic stroke
neurovascular intervention
Lead sponsor: MIVI Neuroscience, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Successful Revascularization Rate
timeFrame: intra-procedural
measure: Symptomatic Intracranial Haemorrhage Rate
timeFrame: 24 hours post procedure
Secondary outcomes:
measure: Successful Revascularization Rate Using the Q Aspiration Catheter as the Only Thrombectomy Device
timeFrame: intra-procedural
measure: Rate of Embolization to a New Neurovascular Territory (ENT)
timeFrame: intra-procedural
measure: Good Functional Outcome Measured by Modified Rankin Scale Score of 0-2
timeFrame: 90 days
measure: Mortality Rate
timeFrame: 90 days
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario 12 De Octubre
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
city: San Sebastián
country: Spain
facility: Centro Hospitalario Universitario Donostia
city: Santiago De Compostela
country: Spain
facility: Hospital Universitario de Santiago de Compostela
Study officials:
affiliation: Neurorradiologia Intervencionista, HCUVA, Murcia
name: Mariano Espinosa de Rueda Ruiz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.