Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-24 @ 12:47 PM
NCT ID:
NCT01994161
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic status: as evidenced by TIA or non-severe stroke within the past 12 months attributed to 70% to 99% stenosis of a major intracranial artery (carotid artery, MCA stem \[M1\], vertebral artery, or basilar artery).
* Degree of stenosis: 70%-99%; (Stenosis must be confirmed by catheter angiography for enrollment in the trial,WASID method)
* Age:30-80 years;
* No fresh infarctions identified on MRI (indicated as high signals on DWI series) upon enrollment
* No massive cerebral infarction (\>1/2 MCA territory), intracranial hemorrhage, epidural or sub-dural hemorrhage, and intracranial brain tumor on CT or MRI scan
* mRS scale score of \<=2
* Target vessel reference diameter must be measure d to be 2.00 mm to 4.50 mm; target area of stenosis is \<=14 mm in length
* Patient is willing and able to return for all follow-up visits required by the protocol
* Patient understands the purpose and requirements of the study, can make him/herself understood, and has signed informed consent.
Exclusion Criteria:
* Untoward reaction to anesthesia.
* Any condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe.
* Tandem extracranial or intracranial stenosis that is proximal or distal to the target intracranial lesion
* Previous treatment of target lesion with a stent, angioplasty, or other mechanical device.
* Any aneurysm proximal to or distal to stenotic intracranial artery. Intracranial tumor (except meningioma) or any intracranial vascular malformation
* Computed tomographic or angiographic evidence of severe calcification at target lesion
* Stroke of sufficient size (\>5cm on CT or MRI) to place patient at risk of hemorrhagic conversion during the procedure.Hemorrhagic transformation of an ischemic stroke within the past 15 days.
* Previous spontaneous intracerebral (parenchymal) or other intracranial (subarachnoid, subdural, or epidural) hemorrhage within 30 days
* Untreated chronic subdural hematoma \>5 mm in thickness
* Intracranial arterial stenosis related to arterial dissection, moya-moya disease or any known vasculitic disease;
* MI within previous 30 days
* Any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation
* Intolerance or allergic reaction to any of the study medications, including aspirin, clopidogrel, heparin, nitinol, and local or general anaesthesia History of life-threatening allergy to contrast dye. If not life-threatening and can be effectively pretreated, patient can be enrolled at physicians discretion
* Recent GI bleed that would interfere with antiplatelet therapy. Active bleeding diathesis or coagulopathy; active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets count \<125,000, hematocrit \<30, Hgb \<10 g/dl, uncorrected INR \>1.5, bleeding time \>1 minute beyond upper limit normal, or heparin-associated thrombocytopenia that increases the risk of bleeding, uncontrolled severe hypertension (systolic BP\>180 mm hg or diastolic BP\>115 mm hg), severe liver impairment (AST or ALT \>3 times normal, cirrhosis), creatinine \>265.2μmol/l (unless on dialysis)
* Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 90 days after enrollment
* Severe dementia or psychiatric problem that prevents the patient from following an outpatient program reliably
* Pregnancy or of childbearing potential and unwilling to use contraception for the duration of this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT01994161
Study Brief:
Protocol Section:
NCT01994161