This trial is active, not recruiting.

Condition stroke, acute
Sponsor ev3
Collaborator ev3 International
Start date October 2010
Trial size 210 participants
Trial identifier NCT01327989, ev3-02-2010


The purpose of this observational clinical evaluation is to evaluate the safety and efficacy of the Solitaire FR Device in subjects requiring mechanical thrombectomy when used according to its Instruction For Use (IFU), in real life practice.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Arterial recanalization of the occluded target vessel measured by Thrombolysis in Cerebral Infarction (TICI) score equal or superior to 2b following the use of the Study Device.
time frame: Immediately post procedure (day 1)

Secondary Outcomes

Rate of device-related and procedure related Serious Adverse Events (SAEs) as a measure of safety.
time frame: At hospital discharge or at 10 days post procedure if patient not discharged.
Time to revascularisation
time frame: Post procedure

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: - Patient or patient's legally authorized representative received information about data collection or if mandatory, has signed and dated an Informed Consent Form - Age ≥ 18 and < 85 years - Clinical signs and imaging criteria consistent with acute ischemic stroke - Thrombolysis in Cerebral Infarction TICI 0 or TICI 1 flow in proximal anterior intracranial vasculature (M1 or M2 of Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA) intracranial, Internal carotid Artery (ICA) terminal) - Presentation within 8 hours of stroke on set according to local stroke protocol - If stroke presentation within 4.5hours, one of these conditions can be met: - Bridging protocol (starting intravenous and continuing with intra-arterial) (up to maximum 0.9mg/kg) - Failed Intravenous thrombolysis - Direct Intra-Arterial treatment (according to institution guidelines) - Patient is willing to conduct follow-up visits - National Institute of Health Stroke Scale (NIHSS) ≥ 8 and ≤ 30 - modified Rankin Scale (mRS) ≤ 2 prior to stroke onset Exclusion Criteria: - Females who are pregnant or lactating - Known serious sensitivity to radiographic contrast agents - Neurological signs that are rapidly improving prior to or at time of treatment - Current participation in another investigational drug or device study - Life expectancy of less than 90 days - National Institute of Health Stroke Scale (NIHSS) > 30 or coma - Uncontrolled hypertension defined as systolic blood pressure > 185 or diastolic blood pressure > 110 that cannot be controlled except with continuous parenteral antihypertensive medication - Use of warfarin anticoagulation with INR (International Normal Ratio) > 3.0 - Platelet count < 30,000 - Glucose > 400 mg/dL - Previous stroke within 30 days - Time of symptom onset unknown - Seizure at the onset of stroke - Myocardial infarction or infection (sepsis or endocarditis) - Arterial tortuosity that would prevent the device from reaching the target vessel - Known hypersensitivity to nickel-titanium - Angiographic evidence of carotid dissection, complete cervical carotid occlusions, or vasculitis, - Stenosis proximal to thrombus site that may preclude safe recovery of the device - Brain CT with signs of hemorrhage, avm or aneurysm - Erly ischemic changes > 1/3 of the middle cerebral artery (MCA) territory or according to brain CT ASPECT score ≤ 6 or according to Diffusion Weighted Magnetic Resonnance Imaging (MR DWI)

Additional Information

Official title STAR: Solitaire FR Thrombectomy for Acute Revascularisation
Principal investigator Vitor Mendes Pereira, Dr
Trial information was received from ClinicalTrials.gov and was last updated in August 2012.
Information provided to ClinicalTrials.gov by ev3.