Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO)

Stryker

Status and phase: Completed; Phase 4

Conditions: Ischemic Stroke

Treatments: Procedure: Mechanical Thrombectomy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01088672

DQR0036

Details and patient eligibility

About

To determine the revascularization rate of the CE-marked Trevo device in large vessel occlusions in ischemic stroke patients.

• Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure.

Full description

• Clinical outcomes at 90 days
• Mortality at 90 days
• Device-related serious adverse events (DRSAEs)
• Symptomatic ICH rate within 24 (-6/+12) hours post-procedure

Enrollment: 60 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-79 (has had 18th birthday, but not yet had 80th birthday)
• NIHSS 8 - 30
• Anticipated life expectancy of at least 6 months
• No significant pre-stroke disability (mRS less than or equal to 1)
• Written informed consent to participate given by patient or legal representative
• Angiographic confirmation of a persistent large vessel occlusion, in the internal carotid, middle cerebral M1 and/or M2 segments, basilar or vertebral arteries
• Treatable within 8 hours of symptom onset, defined as the first pass being made with the Trevo device.

Exclusion criteria

• Baseline glucose of < 50 mg/dL (2.78 mmol) or > 400 mg / dL (22.20 mmol)
• Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0
• Treated with Heparin within 48 hours with a PTT greater than 2 times the lab normal
• Baseline platelet count < 30,000
• History of severe allergy (more than rash) to contrast medium
• Severe, sustained hypertension (SBP > 185 mm Hg or DBP > 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using medication (i.e. Nipride), the patient can be enrolled
• Woman of child bearing potential who is known to be pregnant
• Patient participating in another clinical study or protocol
• For anterior circulation strokes: strokes involving greater than 1/3 of the MCA territory, as determined by hypodensity on the baseline non- contrast CT, or low CBV on CT Perfusion imaging, or restricted diffusion on DWI images
• For posterior circulation strokes within the midbrain and/or pons, extensive hypodensity on the baseline CT, or low CBV on CT Perfusion imaging, or extensive restricted diffusion on DWI images
• Baseline CT/MR evidence of significant mass effect with midline shift
• Baseline CT/MR evidence of hemorrhage
• Baseline CT/MR evidence of intracranial tumor (except small meningioma)
• Angiographic evidence of vasculitis or arterial dissection
• High grade stenosis that cannot be treated safely or which prevents access to the thrombus with the Trevo device
• Angiographic evidence of excessive arterial tortuosity that precludes the Trevo device from reaching the thrombus

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Acute Ischemic Stroke

Other group

Description:

Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke

Treatment:

Procedure: Mechanical Thrombectomy