A Study of the Use of the Q Aspiration Catheter to Remove Clot in Stroke Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-16

Study Completion Date

2021-11-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke, Ischemic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Q Aspiration Catheter

mechanical thrombectomy for acute ischemic stroke

Q Aspiration Catheter

Intervention Type DEVICE

The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in the neurovascular system.

Interventions

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Q Aspiration Catheter

The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in the neurovascular system.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No