Evaluation of the ReVive SE Device for Intra-Arterial Thrombectomy in Acute Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2017-05-31

Brief Summary

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The main objective of this study is to assess the safety and effectiveness of the ReVive SE (Self- Expanding) Neurothrombectomy Device in subjects requiring mechanical thrombectomy when used according to its Instruction for use (IFU).

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Detailed Description

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Conditions

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Stroke

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years old
2. Clinical signs consistent with acute ischemic stroke
3. No pre-stroke functional dependence (pre-stroke Modified Rankin Score ≤ 1)
4. NIHSS ≥ 6,, assessed within two hours before treatment with ReVive SE
5. Large (≥ 1.5mm) and proximal vessel occlusion (presenting TICI score of 0 or 1) of MCA (M1-M2), dICA, or BA confirmed by CT/MR angiography that it is accessible to the ReVive SE.
6. Treatment initiated within 8 hours after symptom onset (first ReVive SE pass made within 6 hours
7. Subject or legally authorized representative has provided informed consent on data collection, and consent is documented

Exclusion Criteria

1. Life expectancy of less than 90 days
2. Neurological signs that are rapidly improving prior to or at time of treatment (NIHSS improves at least 4 points between subject presentation and treatment initiation)
3. Subject is either exhibiting clinical signs suggestive of, or there is angiographic evidence of bilateral stroke
4. Prior use of any other mechanical device to treat this stroke (e.g., Merci Retriever, Penumbra, Solitaire, Trevo, Mindframe, Phenox, stent)
5. Known bleeding diathesis:

1. Current use of oral anticoagulants (eg, warfarin sodium) with International Normalized Ratio (INR) \> 3;
2. Administration of heparin or Novel Oral AntiCoagulants (NOAC, eg Dabigatran, Rivaroxaban) within 48 hours preceding the onset of stroke and have an abnormal activated partial thromboplastin time (aPTT) at presentation; and/or
3. Platelet count \< 100,000/mm3
6. Glucose \<50 mg/dL (2.8 mmol, 2.6mM)
7. Uncontrolled hypertension (SBP\>185 or DBP\>110) refractory to pharmacological management
8. Known hypersensitivity or allergy to nitinol and/or radiographic contrast agents
9. Pregnancy or lactating female
10. Subject already enrolled in a clinical study involving experimental medication or device

11. CT scan or MRI with evidence of acute intracranial hemorrhage, mass effect and/or intracranial tumor.
12. Angiographic evidence of carotid dissection, or high grade stenosis (\> 50% stenosis of the artery proximal to the target vessel) that will prevent access to the clot, or cerebral vasculitis
13. Blood vessel with extreme tortuosity or other conditions preventing the access of the device.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No