Solitaire FR Thrombectomy for Acute Revascularisation (STAR)
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ClinicalTrials.gov Identifier: NCT01327989 |
Recruitment Status :
Completed
First Posted : April 4, 2011
Results First Posted : January 27, 2017
Last Update Posted : January 27, 2017
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Condition or disease | Intervention/treatment |
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Stroke, Acute | Device: Solitaire™ FR device |
Study Type : | Observational |
Actual Enrollment : | 202 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | STAR: Solitaire FR Thrombectomy for Acute Revascularisation |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | January 2013 |
Group/Cohort | Intervention/treatment |
---|---|
Solitaire™ FR device
Eligible subjects treated with the Solitaire™ FR device.
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Device: Solitaire™ FR device
Mechanical Thrombectomy |
- 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.
- Time to Achieve Revascularization - Groin Stick to Initial Angiogram and Final Solitaire™ FR Angiogram [ Time Frame: During procedure ]
Time from groin stick to initial angiogram and final Solitaire™ FR angiogram with Thrombolysis in Cerebral Infarction (TICI) score 2b or 3 flow
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
- Time to Achieve Revascularization - After First Ipsilateral Angiogram to Final Solitaire™ FR Angiogram [ Time Frame: During Procedure ]
Time after first ipsilateral angiogram to final Solitaire™ FR angiogram with Thrombolysis in Cerebral Infarction (TICI) score 2b or 3 flow
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
- Good Neurological Condition [ Time Frame: 90 Days ]Good neurological outcome (GNO), as defined in the protocol, is a modified Rankin Scale (mRS) score of less than or equal to 2, or National Institutes of Health Stroke Scale (NIHSS) score 0-1, or NIHSS score improvement of 10 points or more from the pre-procedure evaluation
- Rate of Morbidity [ Time Frame: 90 Days ]
- Rate of Mortality [ Time Frame: 90 Days ]
- Incidence of Symptomatic Intracranial Hemorrhage [ Time Frame: 24 hours ]
Symptomatic intracranial hemorrhage, defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a decline in National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24 hrs.
PH1 - Hematoma within ischemic field with some mild space occupying effect but involving ≤ 30% PH2 - Hematoma within ischemic field with space-occupying effect involving > 30% of the infarcted area RIH - Any intraparenchymal hemorrhage remote from the ischemic field IVH - Intraventricular hemorrhage SAH - Subarachnoid hemorrhage
- Immediate Flow Reperfusion [ Time Frame: procedure ]
Immediate reperfusion observed when the Solitaire™ FR device is deployed within the thrombus - Thrombolysis in Cerebral Infarction (TICI) score 2b or 3.
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

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Ages Eligible for Study: | 18 Years to 84 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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
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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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01327989
Switzerland | |
Inselspital University Hospital of Bern | |
Bern, Switzerland, 3010 | |
Hôpitaux Universitaires de Genève (HUG) | |
Geneva, Switzerland, 1211 |
Principal Investigator: | Vitor Mendes Pereira, Dr | HUG Geneva | |
Principal Investigator: | Jan Gralla, Dr | Inselspital University Hospital of Bern |
Responsible Party: | Medtronic Neurovascular Clinical Affairs |
ClinicalTrials.gov Identifier: | NCT01327989 |
Other Study ID Numbers: |
ev3-02-2010 |
First Posted: | April 4, 2011 Key Record Dates |
Results First Posted: | January 27, 2017 |
Last Update Posted: | January 27, 2017 |
Last Verified: | October 2016 |
Solitaire FR Device Mechanical Thrombectomy Recanalization Brain artery recanalization |
Neurovascular intervention Interventional Neuroradiology STAR Acute Ischemic Stroke |
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |