Please select the eligibility criteria that correspond to the clinical trial below.
Title: RandomizEd Trial of reVascularizAtion With Solitaire FR® Device Versus Best mediCal Therapy in the Treatment of Acute Stroke Due to anTerior Circulation Large Vessel Occlusion Presenting Within 8 Hours of Symptom Onset
Brief Summary: To evaluate the hypothesis that mechanical embolectomy with the Solitaire FR device is superior to medical management alone in achieving favorable outcome in the distribution of the modified Rankin Scale scores at 90 days in subjects presenting with acute large vessel ischemic stroke \< 8 hours from symptom onset.


Options:
A: Inclusion Criteria:

* Age greater than or equal to 18
* NIHSS greater than or equal to 8
* onset of symptoms is less than 5 hours OR symptom/imaging mismatch
* suspected occlusion of the M1 or M2 segment of the MCA, supraclinoid ICA, or basilar trunk.

Exclusion Criteria:

* established infarction of the target symptomatic territory
* co-morbid diseases which suggest a poor 90 day outcome irrespective of management
* radiologic evidence of hemorrhagic transformation of the infarcted territory
B: Inclusion Criteria:

1. Acute ischemic stroke where patient is ineligible for IV thrombolytic treatment or the treatment is contraindicated (e.g., subject presents beyond recommended time from symptom onset), or where patient has received IV thrombolytic therapy without clinical improvement.
2. No significant pre-stroke functional disability (mRS ≤ 1)
3. Baseline NIHSS score obtained prior to randomization must be equal or higher than 8 points
4. Age ≥18 years
5. Occlusion (TICI 0-1) of the intracranial ICA (distal ICA or T occlusions) and/or MCA-M1 segment suitable for endovascular treatment, as evidenced by CTA, MRA or angiogram, with or without concomitant cervical carotid occlusion or stenosis.
6. Patient treatable within eight hours of symptom onset. Symptoms onset is defined as point in time the patient was last seen well (at baseline). Treatment start is defined as groin puncture.
7. Informed consent obtained from patient or acceptable patient surrogate

Exclusion Criteria:

1. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0
2. Baseline platelet count \< 30.000/µL
3. Baseline blood glucose of \< 50mg/dL or \> 400mg/dl
4. Severe, sustained hypertension (SBP \> 185 mm Hg or DBP \> 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using AHA guidelines recommended medication (including iv antihypertensive drips), the patient can be enrolled.
5. Patients in coma (NIHSS item of consciousness \>1) (Intubated patients for transfer could be randomized only in case an NIHSS is obtained by a neurologist prior transportation).
6. Seizures at stroke onset which would preclude obtaining a baseline NIHSS
7. Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
8. History of life threatening allergy (more than rash) to contrast medium
9. Subjects who has received IV t-PA treatment beyond 4,5 hours from the beginning of the symptoms
10. Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.
11. Subject participating in a study involving an investigational drug or device that would impact this study.
12. Cerebral vasculitis
13. Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, mRS score at baseline must be ≤1. This excludes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.)
14. Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas).
15. Hypodensity on CT or restricted diffusion amounting to an ASPECTS score of \<6 on NCCT, or \<5 on DWI MRI. The use of CTP or MRI perfusion is optional.
16. Collaterals with malignant profile on CTA (without colateral circulation on CTA)
17. CT or MR evidence of hemorrhage (the presence of GRE microbleeds is allowed).
18. Significant mass effect with midline shift.
19. Evidence of ipsilateral carotid occlusion, high grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery that cannot be treated or will prevent access to the intracranial clot or excessive tortuosity of cervical vessels precluding device delivery/deployment
20. Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation)
21. Evidence of intracranial tumor (except small meningioma).
C: Inclusion Criteria:

* 1. Acute ischemic stroke where patient is ineligible for IV thrombolytic treatment or the treatment is contraindicated (e.g., subject presents beyond recommended time from symptom onset), or where patient has received IV thrombolytic therapy without recanalization after a minimum of 30 min from start of iv tPA infusion
* 2. No significant pre-stroke functional disability (mRS ≤ 1)
* 3. Baseline NIHSS score obtained prior to randomization must be equal or higher than 6 points
* 4. Age ≥18 and ≤ 85.
* 5. Occlusion (TICI 0-1) of the intracranial ICA (distal ICA or T occlusions), MCA-M1 segment or tandem proximal ICA/MCA-M1 suitable for endovascular treatment, as evidenced by CTA, MRA or angiogram, with or without concomitant cervical carotid occlusion or stenosis
* 6. Patient treatable within eight hours of symptom onset. Symptoms onset is defined as point in time the patient was last seen well (at baseline). Treatment start is defined as groin puncture.
* 7. Informed consent obtained from patient or acceptable patient surrogate

Exclusion Criteria:

* Clinical criteria
* 1. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0
* 2. Baseline platelet count \< 30.000/µL
* 3. Baseline blood glucose of \< 50mg/dL or \>400mg/dl
* 4. Severe, sustained hypertension (SBP \> 185 mm Hg or DBP \> 110 mm Hg)
* 5. Patients in coma (NIHSS item of consciousness \>1) (Intubated patients for transfer could be randomized only in case an NIHSS is obtained by a neurologist prior transportation).
* 6. Seizures at stroke onset which would preclude obtaining a baseline NIHSS
* 7. Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
* 8. History of life threatening allergy (more than rash) to contrast medium
* 9. Subjects who has received iv t-PA treatment beyond 4,5 hours from the beginning of the symptoms
* 10. Renal insufficiency with creatinine ≥ 3 mg/dl
* 11. Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.
* 12. Subject participating in a study involving an investigational drug or device that would impact this study.
* 13. Cerebral vasculitis
* 14. Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, mRS score at baseline must be ≤ 1. This excludes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.)
* 15. Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas).

Neuroimaging criteria:

* 16. Hypodensity on CT or restricted diffusion amounting to an ASPECTS score of \<7 on NCCT or \<6 on DWI MRI. Patients 81 to 85 years old with ASPECTS score on non-contrast CT or DWI MRI \<9 must be excluded. ASPECTS must be evaluated by CBV maps of CT Perfusion, CTA source imaging (CTA-SI) or DWI-MR in patients whose vascular occlusion study (CTA/MRA) confirming qualifying occlusion, is performed beyond 4.5 hours of last seen well.
* 17. CT or MR evidence of hemorrhage (the presence of microbleeds is allowed).
* 18. Significant mass effect with midline shift.
* 19. Evidence of ipsilateral carotid occlusion, high grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery that cannot be treated or will prevent access to the intracranial clot or excessive tortuosity of cervical vessels precluding device delivery/deployment
* 20. Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation)
* 21. Evidence of intracranial tumor (except small meningioma).
D: Inclusion Criteria:

1. From 18 to 85 years of age
2. Present with symptoms consistent with an acute ischemic stroke and eligible for IV rtPA therapy (patients presenting 3-4.5 hrs from symptom onset are not eligible if they are \>80 yrs of age, have a history of stroke and diabetes, anticoagulant use (even if INR is \<1.7) and have a NIHSS score \>25
3. Evidence of a large vessel occlusion in the anterior circulation with a clot length of 8mm or longer
4. NIH Stroke Scale (NIHSS) score 8 or greater or aphasic at presentation
5. Signed informed consent

Exclusion Criteria:

1. History of stroke in the past 3 months.
2. Females who are pregnant
3. Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score 1 or greater
4. Known severe allergy to contrast media
5. Uncontrolled hypertension (defined as systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg)
6. CT evidence of the following conditions at randomization:

   * Significant mass effect with midline shift
   * Any acute ischemic changes in \>1/3 of the affected middle cerebral artery territory
   * Evidence of intracranial hemorrhage
7. Angiographic evidence of tantem extracranial occlusion or an arterial stenosis proximal to the occlusion that requires treatment prior to thrombus removal. Moderate stenosis not requiring treatment is not an exclusion
8. Angiographic evidence of preexisting arterial injury
9. Rapidly improving neurological status prior to randomization
10. Bilateral stroke
11. Intracranial tumors
12. Known history of cerebral aneurysm or arteriovenous malfunction
13. Known hemorrhagic diathesis, coagulation deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of \>1.7
14. Baseline platelets \<50,000
15. Use of IV heparin in the past 48 hours with PPT \>1.5 times the normalized ratio
16. Pre-treatment glucose \<50mg/dL or \>300mg/dL
17. Life expectancy less than 90 days prior to stroke onset
18. Participation in another clinical investigation that could confound the evaluation of the study device

Answer: C