Evaluation of the ReVive SE Device for Intra-Arterial Thrombectomy in Acute Ischemic Stroke (Re-ACT)

C

Codman & Shurtleff

Status

Completed

Conditions

Stroke

Study type

Observational

Funder types

Industry

Identifiers

NCT02169492
NV-PMK-1203

Details and patient eligibility

About

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).

Enrollment

103 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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