Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke (ReFlow)

Universität des Saarlandes

Status and phase

Completed

Phase 2

Conditions

Acute Stroke

Treatments

Device: Solitaire FR, ev3

Study type

Interventional

Funder types

Other

Identifiers

NCT01210729

ReFlow01

Details and patient eligibility

About

The objective of this study is to collect data on the use of the SOLITAIR FR device for treatment of acute ischemic stroke with large artery occlusion i.e. to investigate, whether the application of SOLITAIR is a safe and feasible method for interventional recanalization of large vessels with favorable patient outcome in acute stroke therapy.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18-85 years
Acute ischemic stroke with occlusion if ICA, MCA, VA or BA (TICI 0 or 1 flow) within the first 6 hours

Exclusion criteria

Rapidly improving neurological signs
NHISS>30 or coma
Female patients, who are pregnant or lactating
Use of warfarin anticoagulation with INR > 1.5
Platelet count < 30,000
Glucose < 50 mg/dL
Life expectancy of less than 90 days
Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of hemorrhage on presentation
CT showing hypodensity on presentation