N/A
Completed N=45
A Study of the Use of the Q Aspiration Catheter to Remove Clot in Stroke Patients
Stroke, Ischemic
Source: ClinicalTrials.gov NCT04089917 ↗
Enrolled (actual)
45
Serious AEs
24.4%
Results posted
Sep 2023
Primary outcomePrimary: Successful Revascularization Rate — 42 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Successful Revascularization Rate |
42 | — |
| PRIMARY Symptomatic Intracranial Haemorrhage Rate |
1 | — |
| SECONDARY Successful Revascularization Rate Using the Q Aspiration Catheter as the Only Thrombectomy Device |
25 | — |
| SECONDARY Rate of Embolization to a New Neurovascular Territory (ENT) |
— | — |
| SECONDARY Good Functional Outcome Measured by Modified Rankin Scale Score of 0-2 |
25 | — |
| SECONDARY Mortality Rate |
7 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04089917). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.