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

Stroke Clinical Trial

— Re-ACT  

Official title:

Evaluation of the ReVive SE Device for Intra-Arterial Thrombectomy in Acute Ischemic Stroke: An Observational, Prospective and Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02169492
• Other study ID #: NV-PMK-1203
• Status: Completed
• Phase: N/A
• First received: June 13, 2014
• Last updated: August 4, 2017
• Start date: January 1, 2015
• Est. completion date: May 31, 2017

Study information

• Verified date: August 2017
• Source: Codman & Shurtleff
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux
France	CHU Clermont Ferrand	Clermont Ferrand
France	CHU de Colmar	Colmar
France	CHU Dijon	Dijon
France	CHU Lille	Lille
France	CHU La Timone	Marseille
France	CHU St Etienne	St Etienne
France	Hôpital Bretonneau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Codman & Shurtleff

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	emboli occurence		90
Other	symptomatic intracranial hemorrhage (sICH)		90 days
Other	Mortality		90 days
Primary	modified Rankin Scale	Functional Independence of subjects as defined by modified Rankin Scale (mRS) =2 at 90 days post-procedure.	90 days
Secondary	National Institute of Health Stroke Scale (NIHSS)		90 days