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

Completed

• Conditions: Stroke

• Registration Number: NCT02169492
• Lead Sponsor: Codman & Shurtleff

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-13
• Study First Submitted QC: 2014-06-19
• Study First Posted: 2014-06-23
• Study Start: 2015-01-01
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-04
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
modified Rankin Scale	90 days	Functional Independence of subjects as defined by modified Rankin Scale (mRS) ≤2 at 90 days post-procedure.

Secondary Outcome Measures

Name	Time	Method
National Institute of Health Stroke Scale (NIHSS)	90 days

Trial Locations

Locations (8)

CHU Bordeaux; 🇫🇷 Bordeaux, France

CHU Dijon; 🇫🇷 Dijon, France

CHU La Timone; 🇫🇷 Marseille, France

CHU St Etienne; 🇫🇷 St Etienne, France

Hôpital Bretonneau; 🇫🇷 Tours, France

CHU Clermont Ferrand; 🇫🇷 Clermont Ferrand, France

CHU de Colmar; 🇫🇷 Colmar, France

CHU Lille; 🇫🇷 Lille, France