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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.
 
ClinicalTrials.gov Identifier: NCT02169492
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease
Stroke

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Study Type : Observational
Estimated Enrollment : 103 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of the ReVive SE Device for Intra-Arterial Thrombectomy in Acute Ischemic Stroke: An Observational, Prospective and Multicenter Study
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine




Primary Outcome Measures :
  1. modified Rankin Scale [ Time Frame: 90 days ]
    Functional Independence of subjects as defined by modified Rankin Scale (mRS) ≤2 at 90 days post-procedure.


Secondary Outcome Measures :
  1. National Institute of Health Stroke Scale (NIHSS) [ Time Frame: 90 days ]

Other Outcome Measures:
  1. emboli occurence [ Time Frame: 90 ]
  2. symptomatic intracranial hemorrhage (sICH) [ Time Frame: 90 days ]
  3. Mortality [ Time Frame: 90 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
subjects requiring mechanical thrombectomy
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169492


Locations
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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, France
Sponsors and Collaborators
Codman & Shurtleff
Investigators
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Study Director: Benjamin Hoehn, MD Codman Neuro
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Responsible Party: Codman & Shurtleff
ClinicalTrials.gov Identifier: NCT02169492    
Other Study ID Numbers: NV-PMK-1203
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Codman & Shurtleff:
Thrombectomy
Stroke
ReVive SE
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases