Stroke
Conditions
Keywords
Thrombectomy, Stroke, ReVive SE
Brief summary
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).
Interventions
None listed
Sponsors
Codman & Shurtleff
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 Imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| modified Rankin Scale | 90 days | Functional Independence of subjects as defined by modified Rankin Scale (mRS) ≤2 at 90 days post-procedure. |
Secondary
| Measure | Time frame |
|---|---|
| National Institute of Health Stroke Scale (NIHSS) | 90 days |
Other
| Measure | Time frame |
|---|---|
| emboli occurence | 90 |
| symptomatic intracranial hemorrhage (sICH) | 90 days |
| Mortality | 90 days |
Countries
France
Outcome results
None listed