STAR: Solitaire FR Thrombectomy for Acute Revascularisation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 202
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
Brief Summary
The objective of this study was to obtain prospective clinical data on the safety and efficacy of the Solitaire™ FR device for patients diagnosed with acute ischemic stroke.
Detailed Description
The Study was a multi-center, single-arm, prospective, observational evaluation. The Solitaire™ FR Device has been certified for CE mark. This protocol evaluated the safety and efficacy of the Solitaire™ FR Device when used in routine practice and according to its Instructions for Use.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 84 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject or subject's legally authorized representative has signed and dated an Informed Consent Form
- •Age ≥ 18 and < 85
- •Clinical signs consistent with acute ischemic stroke
- •Thrombolysis in Cerebral Infarction (TICI) 0 or TICI 1 flow in the 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 onset according to local stroke protocol
- •If stroke presentation within 4.5 hours, one of these conditions can be met:
- •Bridging protocol (starting intravenous and continuing with intra-arterial) (Up to maximum 0.9 mg/kg)
- •Failed intravenous thrombolysis
- •Direct Intra-arterial treatment (according to institution guidelines)
- •Subject is willing to conduct follow-up visits.
- •National Institutes 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 Institutes 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 International Normalised Ratio (INR) > 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
- •Imaging Exclusion Criteria:
- •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 computed tomography (CT) with signs of hemorrhage, arteriovenous venous malformations, or aneurysm
- •Early ischemic changes greater than 1/3 of the middle cerebral artery (MCA) territory or according to brain computed tomography (CT) Alberta Stroke Program Early CT (ASPECT) score ≤ 6 or according to magnetic resonance diffusion weighted imaging (MR DWI) ASPECT score <5
Outcomes
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
Thrombolysis in Cerebral Infarction (TICI) score Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (\<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion
Incidence of Device-related and Procedure-related Serious Adverse Events (SAEs).
Time Frame: 90 Days
Device-related and procedure-related Serious Adverse Events (SAEs). A clinically significant procedure complication is defined as a decline in NIHSS of ≥4 or access vessel complication requiring surgery or blood transfusion.
Secondary Outcomes
- Rate of Mortality(90 Days)
- Time to Achieve Revascularization - Groin Stick to Initial Angiogram and Final Solitaire™ FR Angiogram(During procedure)
- Rate of Morbidity(90 Days)
- Time to Achieve Revascularization - After First Ipsilateral Angiogram to Final Solitaire™ FR Angiogram(During Procedure)
- Good Neurological Condition(90 Days)
- Incidence of Symptomatic Intracranial Hemorrhage(24 hours)
- Immediate Flow Reperfusion(procedure)