Solitaire FR Thrombectomy for Acute Revascularisation (STAR)

Medtronic

Status: Completed

Conditions: Stroke, Acute

Treatments: Device: Solitaire™ FR device

Study type: Observational

Funder types: Industry

Identifiers

NCT01327989

ev3-02-2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 202 patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No Healthy Volunteers

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

Trial design

202 participants in 1 patient group

Solitaire™ FR device

Description:

Eligible subjects treated with the Solitaire™ FR device.

Treatment:

Device: Solitaire™ FR device