Solitaire FR Thrombectomy for Acute Revascularisation

Stroke, Acute Clinical Trial

— STAR  

Official title:

STAR: Solitaire FR Thrombectomy for Acute Revascularisation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01327989
• Other study ID #: ev3-02-2010
• Status: Active, not recruiting
• Phase: N/A
• First received: October 12, 2010
• Last updated: August 27, 2012
• Start date: October 2010

Study information

• Verified date: August 2012
• Source: ev3
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionGermany: Ethics CommitteeSpain: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 210
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke, Acute

Locations

Country	Name	City	State
Switzerland	Inselspital University Hospital of Bern	Bern
Switzerland	Hôpitaux Universitaires de Genève (HUG)	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
ev3	ev3 International

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Immediately post procedure (day 1)	No
Secondary	Rate of device-related and procedure related Serious Adverse Events (SAEs) as a measure of safety.		At hospital discharge or at 10 days post procedure if patient not discharged.	Yes
Secondary	Time to revascularisation	From groin stick to final Solitaire FR angiogram (day 1)	Post procedure	No