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. Author manuscript; available in PMC: 2012 Nov 26.
Published in final edited form as: J Stroke Cerebrovasc Dis. 2011 Jul-Aug;20(4):357–368. doi: 10.1016/j.jstrokecerebrovasdis.2011.05.001

Table 1.

INCLUSION CRITERIA

  1. TIA or non-severe stroke within 30 days of enrollment attributed to 70–99% stenosis * of a major intracranial artery (carotid artery, MCA stem (M1), vertebral artery, or basilar artery)

    • *

      may be diagnosed by TCD, MRA, or CTA to qualify for angiogram performed as part of the study protocol but must be confirmed by catheter angiography for enrollment in the trial

  2. Modified Rankin score of ≤ 3

  3. Target area of stenosis in an intracranial artery that has a normal diameter of 2.00 mm to 4.50 mm

  4. Target area of stenosis is less than or equal to 14 mm in length

  5. Age ≥ 30 years and ≤ 80 years.

    • Patients 30–49 years are required to meet at least one additional criteria (i-vi) provided in the table below to qualify for the study. This additional requirement is to increase the likelihood that the symptomatic intracranial stenosis in patients 30–49 years is atherosclerotic.

    i. insulin dependent diabetes for at least 15 years
    ii. at least 2 of the following atherosclerotic risk factors: hypertension (BP ≥ 140/90 or on antihypertensive therapy); dyslipidemia (LDL ≥ 130 mg /dl or HDL < 40 mg/dl or fasting triglycerides ≥150 mg/dl or on lipid lowering therapy); smoking; non-insulin dependent diabetes or insulin dependent diabetes of less than 15 years duration; family history of any of the following: myocardial infarction,coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting,peripheral vascular surgery in parent or sibling who was < 55 years of age for men or < 65 for women at the time of the event
    iii. history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease
    iv. any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery,coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery that was documented by non-invasive vascular imaging or catheter angiography and is considered atherosclerotic
    v. aortic arch atheroma documented by non-invasive vascular imaging or catheter angiography
    vi. any aortic aneurysm documented by non-invasive vascular imaging or catheter angiography that is considered atherosclerotic

  6. Negative pregnancy test in a female who has had any menses in the last 18 months

  7. Patient is willing and able to return for all follow-up visits required by the protocol

  8. Patient is available by phone

  9. Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent