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Solitaire FR Thrombectomy for Acute Revascularisation (STAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01327989
Recruitment Status : Completed
First Posted : April 4, 2011
Results First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Collaborator:
ev3 International
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

Study Description
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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.

Condition or disease Intervention/treatment
Stroke, Acute Device: Solitaire™ FR device

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
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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
Groups and Cohorts
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Group/Cohort Intervention/treatment
Solitaire™ FR device
Eligible subjects treated with the Solitaire™ FR device.
 Device: Solitaire™ FR device
Mechanical Thrombectomy


Outcome Measures
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Primary Outcome Measures :
  1. 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


  2. 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 Outcome Measures :
  1. 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


  2. 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


  3. 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

  4. Rate of Morbidity [ Time Frame: 90 Days ]
  5. Rate of Mortality [ Time Frame: 90 Days ]
  6. 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


  7. 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



Eligibility Criteria
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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
Study Population
Subjects having clinical signs and imaging criteria consistent with acute ischemic stroke who presented within 8 hours of stroke symptoms onset with the study device were considered for inclusion in the study.
Criteria

Inclusion Criteria:

  1. Subject or subject's legally authorized representative has signed and dated an Informed Consent Form
  2. Age ≥ 18 and < 85
  3. Clinical signs consistent with acute ischemic stroke
  4. 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)
  5. Presentation within 8 hours of stroke onset according to local stroke protocol

  6. 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)
  7. Subject is willing to conduct follow-up visits.
  8. National Institutes of Health Stroke Scale (NIHSS) ≥ 8 and ≤ 30
  9. Modified Rankin Scale (mRS) ≤ 2 prior to stroke onset

Exclusion Criteria:

  1. Females who are pregnant or lactating
  2. Known serious sensitivity to radiographic contrast agents
  3. Neurological signs that are rapidly improving prior to or at time of treatment
  4. Current participation in another investigational drug or device study
  5. Life expectancy of less than 90 days
  6. National Institutes of Health Stroke Scale (NIHSS) > 30 or coma
  7. Uncontrolled hypertension defined as systolic blood pressure > 185 or diastolic blood pressure > 110 that cannot be controlled except with continuous parenteral antihypertensive medication
  8. Use of warfarin anticoagulation with International Normalised Ratio (INR) > 3.0
  9. Platelet count < 30,000
  10. Glucose < 400 mg/dL
  11. Previous stroke within 30 days
  12. Time of symptom onset unknown
  13. Seizure at the onset of stroke
  14. Myocardial infarction or infection (sepsis or endocarditis)
  15. Arterial tortuosity that would prevent the device from reaching the target vessel

  16. Known hypersensitivity to nickel-titanium

    Imaging Exclusion Criteria:

  17. Angiographic evidence of carotid dissection, complete cervical carotid occlusions, or vasculitis
  18. Stenosis proximal to thrombus site that may preclude safe recovery of the device
  19. Brain computed tomography (CT) with signs of hemorrhage, arteriovenous venous malformations, or aneurysm
  20. 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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Switzerland
Inselspital University Hospital of Bern
Bern, Switzerland, 3010
Hôpitaux Universitaires de Genève (HUG)
Geneva, Switzerland, 1211
Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
ev3 International
Investigators
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Principal Investigator: Vitor Mendes Pereira, Dr HUG Geneva
Principal Investigator: Jan Gralla, Dr Inselspital University Hospital of Bern
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Medtronic Neurovascular Clinical Affairs:
Solitaire FR Device
Mechanical Thrombectomy
Recanalization
Brain artery recanalization
 Neurovascular intervention
Interventional Neuroradiology
STAR
Acute Ischemic Stroke
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases