Evaluation of the ReVive SE Device for Intra-Arterial Thrombectomy in Acute Ischemic Stroke (Re-ACT)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
subjects requiring mechanical thrombectomy
Age ≥ 18 years old
Clinical signs consistent with acute ischemic stroke
No pre-stroke functional dependence (pre-stroke Modified Rankin Score ≤ 1)
NIHSS ≥ 6,, assessed within two hours before treatment with ReVive SE
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.
Treatment initiated within 8 hours after symptom onset (first ReVive SE pass made within 6 hours
Subject or legally authorized representative has provided informed consent on data collection, and consent is documented
Life expectancy of less than 90 days
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)
Subject is either exhibiting clinical signs suggestive of, or there is angiographic evidence of bilateral stroke
Prior use of any other mechanical device to treat this stroke (e.g., Merci Retriever, Penumbra, Solitaire, Trevo, Mindframe, Phenox, stent)
Known bleeding diathesis:
Current use of oral anticoagulants (eg, warfarin sodium) with International Normalized Ratio (INR) > 3;
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
Platelet count < 100,000/mm3
Glucose <50 mg/dL (2.8 mmol, 2.6mM)
Uncontrolled hypertension (SBP>185 or DBP>110) refractory to pharmacological management
Known hypersensitivity or allergy to nitinol and/or radiographic contrast agents
Pregnancy or lactating female
Subject already enrolled in a clinical study involving experimental medication or device
Imaging Exclusion criteria:
CT scan or MRI with evidence of acute intracranial hemorrhage, mass effect and/or intracranial tumor.
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
Blood vessel with extreme tortuosity or other conditions preventing the access of the device.