Clinical trial NCT02169492: Evaluation of the ReVive SE Device for Intra-Arterial Thrombectomy in Acute Ischemic Stroke
Official title: Evaluation of the ReVive SE Device for Intra-Arterial Thrombectomy in Acute Ischemic Stroke: An Observational, Prospective and Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Thrombectomy
Stroke
ReVive SE
Lead sponsor: Codman & Shurtleff
Sponsor class: INDUSTRY
First posted: 2014-06-23
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects requiring mechanical thrombectomy

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).


Eligibility criteria: 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 Exclusion criteria:
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.

Primary outcomes:
measure: modified Rankin Scale
timeFrame: 90 days
Secondary outcomes:
measure: National Institute of Health Stroke Scale (NIHSS)
timeFrame: 90 days
Other outcomes:
measure: emboli occurence
timeFrame: 90
measure: symptomatic intracranial hemorrhage (sICH)
timeFrame: 90 days
measure: Mortality
timeFrame: 90 days
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand
city: Colmar
country: France
facility: CHU de Colmar
city: Dijon
country: France
facility: CHU Dijon
city: Lille
country: France
facility: CHU Lille
city: Marseille
country: France
facility: CHU La Timone
city: St Etienne
country: France
facility: CHU St Etienne
city: Tours
country: France
facility: Hôpital Bretonneau
Study officials:
affiliation: Codman Neuro
name: Benjamin Hoehn, MD
role: STUDY_DIRECTOR
References: