N/A
Completed N=102
Prospective Evaluation to Characterize the Real-World Performance of the EMBOVAC Aspiration Catheter
Source: ClinicalTrials.gov NCT04531904 ↗Enrolled (actual)
102
Serious AEs
25.5%
Results posted
Jan 2024
Primary outcomePrimary: Percentage of Participants With Successful Revascularization — 98.0 Percentage of participants
Summary
A post-market study evaluating the EMBOVAC Aspiration Catheter in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Successful Revascularization |
98.0 | — |
| SECONDARY Percentage of Participants With Successful Revascularization Without Rescue Therapy |
87.9 | — |
| SECONDARY Percentage of Participants With Complete Revascularization |
86.9 | — |
| SECONDARY Percentage of Participants With First Pass Effect Without Rescue Therapy |
53.5 | — |
| SECONDARY Percentage of Participants With Modified First Pass Effect |
72.7 | — |
| SECONDARY Time to Recanalization |
27.8 | — |
| SECONDARY Percentage of Participants With Modified Rankin Scale (mRS) Scores 0 to 2 at Day 90 |
56.6 | — |
| SECONDARY Percentage of Participants With Device Related Serious Adverse Events (SAEs) |
1.0 | — |
| SECONDARY Percentage of Participants With Symptomatic Intracerebral Hemorrhage (sICH) |
— | — |
| SECONDARY Change From Baseline in National Institutes of Health Stroke Scale (NIHSS) Total Score at 24 Hours Post-procedure |
-6.9 | — |
| SECONDARY Number of Participants With All-Cause Mortality Thorugh 90 Days |
13 | — |
Eligibility Criteria
Inclusion Criteria
- Subject ≥ 18 years old.
- Subject experiencing acute ischemic stroke with angiographic confirmation of Large Vessel Occlusion of the distal intracranial internal carotid artery, middle cerebral artery or anterior cerebral artery
- A clinical decision has been made to use the EMBOVAC™ aspiration catheter prior to enrollment in the research
- EMBOVAC™ Aspiration Catheter is attempted to be used for the first 3 clot removal passes for the target intracranial occlusion
- Pre-stroke mRS ≤ 1
- NIHSS ≤ 30
- Informed Consent has been provided by the subject or the subject's legally authorized representative.
Exclusion Criteria
- Potential study candidate has already undergone standard of care assessments or treatment that deviate from the clinical research protocol requirements
- All patients with severe hypertension on presentation. All patients, in whom intravenous therapy with blood pressure medications is indicated, with hypertension that remains severe and sustained despite intravenous antihypertensive therapy
- Known cerebral vasculitis.
- Known cancer with life expectancy less than 12 months.
- Stenosis, or any occlusion, in a vessel proximal to the target occlusion that requires treatment or prevents access to the site of occlusion.
- Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
- Baseline computed tomography (CT) or MRI showing mass effect or intracranial tumor (except small meningioma).
- Evidence of dissection in the extra or intracranial cerebral arteries.
- Occlusions in multiple vessels.
- Confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication).
- Currently participating in an investigational clinical trial that may confound study endpoints.
Data sourced from ClinicalTrials.gov (NCT04531904). 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.