Solitaire FR Thrombectomy for Acute Revascularisation

Completed

• Conditions: Stroke, Acute
• Interventions: Device: Solitaire™ FR device

• Registration Number: NCT01327989
• Lead Sponsor: Medtronic Neurovascular Clinical Affairs

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 Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2011-04-01
• Study First Posted: 2011-04-04
• Primary Completion: 2012-10
• Study Completion: 2013-01
• Status Verified: 2016-10
• Results First Submitted: 2016-10-12
• Results First Submitted QC: 2016-12-05
• Last Update Submitted: 2016-12-05
• Results First Posted: 2017-01-27
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Solitaire™ FR device	Solitaire™ FR device	Eligible subjects treated with the Solitaire™ FR device.

Primary Outcome Measures

Name	Time	Method
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	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).	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

Name	Time	Method
Rate of Mortality	90 Days
Time to Achieve Revascularization - Groin Stick to Initial Angiogram and Final Solitaire™ FR Angiogram	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
Rate of Morbidity	90 Days
Time to Achieve Revascularization - After First Ipsilateral Angiogram to Final Solitaire™ FR Angiogram	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	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
Incidence of Symptomatic Intracranial Hemorrhage	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	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

Trial Locations

Locations (2)

Inselspital University Hospital of Bern; 🇨🇭 Bern, Switzerland

Hôpitaux Universitaires de Genève (HUG); 🇨🇭 Geneva, Switzerland