Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase III Study of Pharos Vitesse Neurovascular Stent System Compared to Best Medical Therapy for the Treatment of Ischemic Disease
Brief Summary: The main objective of this study is to prospectively evaluate the safety, probable benefit, and effectiveness of the PHAROS Vitesse Neurovascular Stent System in a multicenter, randomized clinical trial.

A secondary objective of this study is to evaluate the impact of stenting in the neurovasculature to treat cerebral ischemia on other outcomes such as hospital length of stay, charges, and costs.


Options:
A: Inclusion Criteria:

1. Subject has at least one neurovascular lesion (70-99%) stenosis \[internal carotid, middle cerebral, vertebral artery (C4-BA), and/or basilar artery\] symptomatic with a hard TIA or stroke attributable to the territory of the lesion within the past 30 days. An intracranial tandem lesion (50-99%) stenosis may be treated if normal artery segment is sufficient length to avoid overlapping stents.
2. Target vessel diameter / lesion length measurements are within one of the below per angiogram:

   * Vessel diameter is ≥ 2.0 mm and \< 2.5 mm / lesion length is ≤ 16 mm, or
   * Vessel diameter is ≥ 2.5 mm and \< 3.0 mm / lesion length is ≤ 18 mm, or
   * Vessel diameter is ≥ 3.0 mm and \< 4.5 mm / lesion length is ≤ 26 mm, or
   * Vessel diameter is ≥ 4.5 mm and ≤ 5.0 mm / lesion length is ≤ 31 mm
3. Subject has normal artery adjacent to each stenosis; diameter 2.0 mm - 5.0 mm
4. Subject age is 18-85 years
5. Life expectancy is at least 2 years
6. Subject 's mRS score is ≤ 3
7. Subject is available for study follow-up visits (e.g., lives within 3 hours of research center)
8. Subject is willing and cognitively able to provide Informed Consent (consent may be indicated verbally and signed by neutral witness if stroke has impaired hand or visual function)

Exclusion Criteria:

1. Subject has contraindications for balloon expandable stent, e.g.

   * Extreme tortuosity at, or proximal to, target lesion,
   * More than 2 lesions with \> 50% stenosis (including vertebral ostia and common carotid disease),
   * Carotid or vertebral dissection
2. CT scan or MRI evidence of any of the following:

   * Intracranial hemorrhage of type PH1 or PH2
   * Subdural or epidural hemorrhage
   * Mass effect, or
   * Intracranial tumor (except small meningioma)
3. Subject has a previous stent in the territory of the target lesion(s)
4. Subject has a previous coil or clip placed in the territory of the target lesion within 6 months
5. Subject has a potential source of cardiac embolism requiring anticoagulation therapy (e.g., atrial fibrillation, intracardiac thrombus or vegetation, significant mitral stenosis, mechanical heart valve, congestive heart failure with EF \<30%, or endocarditis)
6. Subject has concurrent intracranial pathology, e.g.

   * Moyamoya
   * Vasculitis documented by biopsy results
   * Ruptured Aneurysm
   * Unruptured aneurysm \> 7mm
7. Subject has uncontrolled hypertension (systolic \>185 mmHg or diastolic \>110 mmHg)
8. Hemoglobin \< 10 g/dL; platelet count \< 100,000; or INR \> 1.5 (e.g., use of warfarin)
9. Subject has an uncorrectable bleeding diathesis
10. Subject's neurological status is unstable and rapidly declining (NIHSS score increased \> 4 points within 48 hours prior to randomization)
11. Subject has a contraindication for combination antithrombotic treatment (e.g., clopidogrel and aspirin) such as peptic ulcer disease
12. Subject history indicates high risk of non-compliance (e.g., substance abuse, psychosocial issues, etc.)
13. Subject has a known history contraindicating contrast dye or iodine (vs. sensitivity which can be safely controlled by antihistamine, steroid, etc.)
14. Subject is pregnant or plans to become pregnant in the next 12 months
15. Myocardial infarction within past 3 months
16. Treatment with tPA or other thrombolytic agent within 48 hours prior to randomization
17. Major surgery or trauma within 2 weeks prior to randomization
18. Enrollment in another investigational device or drug study that may confound the results
B: INCLUSION:

Small subcortical ischemic stroke or subcortical TIA.

Inclusion criteria are based on TOAST criteria supplemented by required MRI data. All of the following criteria must be met:

* One of the lacunar stroke clinical syndromes (adapted from Fisher) lasting \> 24 hrs within the past 6 months
* Absence of signs or symptoms of cortical dysfunction such as aphasia, apraxia, agnosia, agraphia, homonymous visual field defect, etc.
* No ipsilateral cervical carotid stenosis (≥50%) by a reliable imaging modality done in an approved laboratory since the qualifying small subcortical stroke (S3), if hemispheric.
* No major-risk cardioembolic sources requiring anticoagulation or other specific therapy. Minor-risk cardioembolic sources will be permitted if anticoagulation is not prescribed by the patient's primary care physician.
* Subcortical TIA with corresponding lesion on DWI.
* MRI evidence of S3: a. Presence of an S3 (1.5 and 2 cm in diameter corresponding to the qualifying event on DWI; when TIA, ADC image must confirm lesion or T2/FLAIR (hyperintense lesions) (required for all brainstem events) OR multiple S3s on FLAIR/TI(\<1.5 cm in diameter) (hypointense lesions) b. Absence of cortical stroke and large subcortical stroke (recent or remote).

EXCLUSION:

To be eligible for entry into the study, the patient must not meet any of the criteria listed below:

* Disabling stroke (Modified Rankin Scale less than or equal to 4)
* Previous intracranial hemorrhage (excluding traumatic) or hemorrhagic stroke
* Age under 30 years
* High risk of bleeding (e.g. recurrent GI or GU bleeding, active peptic ulcer disease, etc)
* Anticipated requirement for long-term use of anticoagulants (e.g. recurrent DVT) or other antiplatelets
* Prior cortical stroke (diagnosed either clinically or by neuroimaging), or prior cortical or retinal TIA
* Prior ipsilateral carotid endarterectomy
* Impaired renal function: GFR \<40
* Intolerance or contraindications to aspirin or clopidogrel (including thrombocytopenia, prolonged INR)
* A score \< 24 (adjusted for age and education) on the Folstein Mini Mental Status Examination
* Medical contraindication to MRI
* Pregnancy or women of child-bearing potential who are not following an effective method of contraception
* Geographic or social factors making study participation impractical
* Unable or unwilling to provide informed consent
* Unlikely to be compliant with therapy/unwilling to return for frequent clinic visits
* Patients concurrently participating in another study with an investigational drug or device
* Other likely specific cause of stroke (e.g. dissection, vasculitis, prothrombotic diathesis, drug abuse)
C: Inclusion Criteria:

18\~80 years old; Primary or recurrent symptomatic intracranial arteriostenosis ineffective through the internal medicine treatment (i.e. stroke or TIA within 90 days during the treatment with at least one anti-thrombotic drugs and vascular risk factor intervention (e.g. hypotensors for hypertension and hypolipidemics for hyperlipidemia);

* 70% stenosis of intracranial responsible angiopathic area under the DSA angiography (as judged through the WASID method);
* 2mm diameter and \<15mm length of ill blood vessel, but normal distal blood vessel

Poor blood circulation in the side branch of responsible angiopathic area under the radiography within one week before the operation:

Blood flow rate peak of ≥200cm/s at the systolic phase under the transcranial doppler ultrasonic examination (TCD); and Low perfusion in the responsible angiopathic area under the skull perfusion CT (i.e. at a decrease of more than 30% over the perfusion at the opposite side); or \<4 scores of blood circulation in the side branch under the DSA; or Hemodynamic ischemic foci under the skull MRI; or Poor blood circulation in the side branch of responsible angiopathic area under the single photon emission computer tomography (SPECT)

Exclusion Criteria:

* \>50% stenosis beyond the responsible intracranial artery Acute ischemic stroke within 3 weeks Obstruction of bypass branch of ill simple carrier artery under the skull MRI Non-atherosclerotic lesion: MoyaMoya disease, any known vascular inflammatory disease, herpes zoster, angiopathy caused by the chicken-pox, herpes zoster or other viruses, neurosyphilis, other intracranial infections, radioactive angiopathy, maldevelopment of fibrous muscle, sickle-cell anemia, neurofibroma, benign angiopathy of central nervous system, postpartum angiopathy, suspicious vasospasm, and recanalization of suspicious thrombosis Intracranial hemorrhage in the angiopathic area within 6 weeks; Potential source for cardiac embolism Concomitant intracranial tumor, aneurysm or intracranial arteriovenous malformation \>50% stenosis of extracranial carotid or vertebral artery at the same side as intracranial angiopathic area; Known contraindications for heparin, Aspirin, Clopidogrel, anesthetics and contrast medium; hemoglobin \<10g/dl, and blood platelet count \<100000 Serious neural dysfunction due to the responsible angiopathy as the sequel of cerebral infarction (mRS≥3) International normalization ratio (INR) \>1.5 (irreversible), uncorrectable hemorrhagic factor; life expectancy due to the illness \<1 year Pregnant/lactating women Inapplicable for intravascular treatment in the viewpoints of investigators
D: Inclusion Criteria:

* Patients aged from 18 to 70 years.
* Complaints of a Symptomatic ICAS: a history of recurrent transient ischemic attacks or an ischemic stroke within 1 year owing to a 70%-99% stenosis in an internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery.
* A length ≤ 15mm of a stenosis in the target vessel and a vessel size \>2.5mm.
* Hypoperfusion in the territory of the target vessels, which is determined by CT or MRI in 14 days before stenting.
* CT or MRI scans show no massive cerebral infarction (beyond half of the territory of middle cerebral artery (MCA)), intracranial hemorrhage, epidural or sub-dural hemorrhage, and intracranial brain tumor.
* Patients who understand the purpose of the study and have provided informed consent.

Exclusion Criteria:

* Not able to receive general anesthesia.
* Not able to receive angiographic assessment.
* A stenosis \>50% in an extracranial carotid or vertebral artery on the ipsilateral side.
* Infarctions due to the perforators occlusion (determined by MRI scan), which is defined as basal ganglia or brainstem/thalamus infarction related with middle cerebral artery or basilar artery stenosis.
* A high risk (leading to a stroke or death) to deliver the stent to the lesion.
* A previous stent or angioplasty in the target lesion.
* Progressive neurological signs within 24 hours before enrolment
* Any haemorrhagic infarct within 14 days before enrolment
* The presence of a cardiac source of embolus
* Thrombolytic therapy within 24 hours before enrollment
* Presence of intraluminal thrombus proximal to or at the target lesion
* Myocardial infarction within previous 30 days
* Non-atherosclerotic lesions: arterial dissection, moya-moya disease; vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebrospinal fluid pleocytosis; radiation-induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process, and suspected recanalized embolus.
* Known contraindications for aspirin and clopidogrel treatment.
* An modified Rankin scale≥3.
* With a childbearing potential or a positive pregnancy test in 1 week before enrolment.

Answer: A