Solitaire FR Thrombectomy for Acute Revascularisation (STAR)

STAR: Solitaire FR Thrombectomy for Acute Revascularisation

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Acute
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 202

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital University Hospital of Bern
  • Geneva, Switzerland, 1211
    • Hopitaux Universitaires de Geneve (HUG)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Solitaire™ FR device; Eligible subjects treated with the Solitaire™ FR device.	Device: Solitaire™ FR device; Mechanical Thrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Immediately post procedure
Incidence of Device-related and Procedure-related Serious Adverse Events (SAEs).	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.	90 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Achieve Revascularization - Groin Stick to Initial Angiogram and Final Solitaire™ FR Angiogram	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	During procedure
Time to Achieve Revascularization - After First Ipsilateral Angiogram to Final Solitaire™ FR Angiogram	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	During Procedure
Good Neurological Condition	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	90 Days
Rate of Morbidity		90 Days
Rate of Mortality		90 Days
Incidence of Symptomatic Intracranial Hemorrhage	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	24 hours
Immediate Flow Reperfusion	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	procedure

Collaborators and Investigators

• Sponsor: Medtronic Neurovascular Clinical Affairs
• Collaborators: ev3 International
• Investigators: Principal Investigator: Vitor Mendes Pereira, Dr, HUG Geneva; Principal Investigator: Jan Gralla, Dr, Inselspital University Hospital of Bern

Publications and helpful links

General Publications

• Raychev R, Saver JL, Jahan R, Nogueira RG, Goyal M, Pereira VM, Gralla J, Levy EI, Yavagal DR, Cognard C, Liebeskind DS. The impact of general anesthesia, baseline ASPECTS, time to treatment, and IV tPA on intracranial hemorrhage after neurothrombectomy: pooled analysis of the SWIFT PRIME, SWIFT, and STAR trials. J Neurointerv Surg. 2020 Jan;12(1):2-6. doi: 10.1136/neurintsurg-2019-014898. Epub 2019 Jun 25. Erratum In: J Neurointerv Surg. 2021 Sep;13(9):e21.
• Coutinho JM, Liebeskind DS, Slater LA, Nogueira RG, Clark W, Davalos A, Bonafe A, Jahan R, Fischer U, Gralla J, Saver JL, Pereira VM. Combined Intravenous Thrombolysis and Thrombectomy vs Thrombectomy Alone for Acute Ischemic Stroke: A Pooled Analysis of the SWIFT and STAR Studies. JAMA Neurol. 2017 Mar 1;74(3):268-274. doi: 10.1001/jamaneurol.2016.5374.
• Menon BK, Almekhlafi MA, Pereira VM, Gralla J, Bonafe A, Davalos A, Chapot R, Goyal M; STAR Study Investigators. Optimal workflow and process-based performance measures for endovascular therapy in acute ischemic stroke: analysis of the Solitaire FR thrombectomy for acute revascularization study. Stroke. 2014 Jul;45(7):2024-9. doi: 10.1161/STROKEAHA.114.005050. Epub 2014 May 15.
• Almekhlafi MA, Davalos A, Bonafe A, Chapot R, Gralla J, Pereira VM, Goyal M; STAR Registry Investigators. Impact of age and baseline NIHSS scores on clinical outcomes in the mechanical thrombectomy using solitaire FR in acute ischemic stroke study. AJNR Am J Neuroradiol. 2014 Jul;35(7):1337-40. doi: 10.3174/ajnr.A3855. Epub 2014 Feb 20.
• Pereira VM, Gralla J, Davalos A, Bonafe A, Castano C, Chapot R, Liebeskind DS, Nogueira RG, Arnold M, Sztajzel R, Liebig T, Goyal M, Besselmann M, Moreno A, Moreno A, Schroth G; the STAR Investigators. Prospective, multicenter, single-arm study of mechanical thrombectomy using Solitaire Flow Restoration in acute ischemic stroke. Stroke. 2013 Oct;44(10):2802-7. doi: 10.1161/STROKEAHA.113.001232. Epub 2013 Aug 1. Erratum In: Stroke. 2013 Dec;44(12):e239. Moreno, Alfredo [corrected to Moreno, Antonio]. Stroke. 2021 Jan;52(1):e48.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: October 12, 2010
• First Submitted That Met QC Criteria: April 1, 2011
• First Posted (Estimate): April 4, 2011

Study Record Updates

• Last Update Posted (Estimate): January 27, 2017
• Last Update Submitted That Met QC Criteria: December 5, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Acute Ischemic Stroke; Recanalization; Interventional Neuroradiology; Mechanical Thrombectomy; Neurovascular intervention; STAR; Solitaire FR Device; Brain artery recanalization
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: ev3-02-2010