Analysis of Revascularization in Ischemic Stroke With EmboTrap (ARISEII)

Neuravi

Status: Completed

Conditions: Stroke; Ischemia

Treatments: Device: EmboTrap® Revascularization Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02488915

CIP002

Details and patient eligibility

About

The study objective is to examine the recanalization efficacy of the EmboTrap device and its associated performance characteristics and to record associated clinical outcomes in a manner that facilitates relevant comparison of outputs with that of devices approved in the U.S. for clearing Large Vessel Occlusions.

Enrollment: 228 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient or the patient's legally authorized representative has signed and dated an Informed Consent Form.

2. Aged between 18 years and 85 years (inclusive).

3. A new focal disabling neurologic deficit consistent with acute cerebral ischemia.

4. NIHSS score ≥8 and ≤25.

5. Pre-ictal mRS score of 0 or 1.

6. The interventionalist estimates that at least one deployment of the EmboTrap device can be completed within 8 hours from the onset of symptoms.

7. Patients for whom IV-tPA is indicated and who are available for treatment, are treated with IV-tPA.

8. IV-tPA, if used, was initiated within 3 hrs of stroke onset (onset time is defined as the last time when the patient was witnessed to be at baseline), with investigator verification that the subject has received/is receiving the correct IV t-PA dose for the estimated weight.

9. Angiographic confirmation of an occlusion of an ICA (including T or L occlusions), M1 or M2 MCA, VA, or BA with mTICI flow of 0 - 1.

10. For strokes in the anterior circulation the following imaging criteria should also be met:

    1. MRI criterion: volume of diffusion restriction visually assessed ≤50 mL. OR
    2. CT criterion: ASPECTS 6 to 10 on baseline CT or CTA-source images, or, volume of significantly lowered CBV ≤50 mL.

11. The patient is indicated for neurothrombectomy treatment by the interventionalist and it is confirmed by diagnostic angiography that the device will be able to reach the target lesion proximally.

Exclusion criteria

1. Life expectancy likely less than 6 months.
2. Females who are pregnant or breastfeeding.
3. History of severe allergy to contrast medium.
4. Known nickel allergy at time of treatment.
5. Known current use of cocaine at time of treatment.
6. Patient has suffered a stroke in the past 3 months.
7. The patient presents with an NIHSS score <8 or >25 or is physician assessed as being in a clinically relevant uninterrupted coma.
8. Subject participating in another study involving an investigational device or drug.
9. Use of warfarin anticoagulation or any Novel Anticoagulant with International Normalized Ratio (INR) >3.0.
10. Platelet count <50,000/μL.
11. Glucose <50 mg/dL.
12. Any known hemorrhagic or coagulation deficiency.
13. Unstable renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR) <30.
14. Patients who have received a direct thrombin inhibitor within the last 48 hours; must have a partial thromboplastin time (PTT) less than 1.5 times the normal to be eligible.
15. All patients with severe hypertension on presentation (SBP> 220mmHg and/or DBP>120mmHg). All patients, in whom intravenous therapy with blood pressure medications is indicated, with hypertension that remains severe and sustained despite intravenous therapy (SBP >185mmHg and/or DBP>110mmHg). .
16. Known cerebral vasculitis.
17. Rapidly improving neurological status.
18. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
19. Ongoing seizure due to stroke.
20. Evidence of active systemic infection.
21. Known cancer with metastases.
22. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
23. Baseline computed tomography (CT) or MRI showing mass effect or intracranial tumor (except small meningioma).
24. Suspicion of aortic dissection, presumed septic embolus, or suspicion of bacterial endocarditis.
25. Stenosis, or any occlusion, in a proximal vessel that requires treatment or prevents access to the site of occlusion.
26. Evidence of dissection in the extra or intracranial cerebral arteries.
27. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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228 participants in 1 patient group

EmboTrap® Revascularization Device

Experimental group

Description:

Mechanical Thrombectomy with EmboTrap

Treatment:

Device: EmboTrap® Revascularization Device