Intervention: ASPIRIN
Trial phase: Phase 2 | Phase 3
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: Medical therapy alone ("Medical Therapy Group")

Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)
Eligibility criteria:
Inclusion Criteria:

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.

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
Subject has normal artery adjacent to each stenosis; diameter 2.0 mm - 5.0 mm
Subject age is 18-85 years
Life expectancy is at least 2 years
Subject 's mRS score is ≤ 3
Subject is available for study follow-up visits (e.g., lives within 3 hours of research center)
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:

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

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)
Subject has a previous stent in the territory of the target lesion(s)
Subject has a previous coil or clip placed in the territory of the target lesion within 6 months
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)

Subject has concurrent intracranial pathology, e.g.

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