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 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT03163459
Eligibility Criteria:
Inclusion Criteria:
* Acute ischemic stroke within 6 hours from symptom onset/last seen well.
* Occlusion (TIMI 0-1) of the basilar artery or distal intracranial carotid artery or middle (M1/M2) or anterior (A1/A2) cerebral artery as evidenced by CTA/MRA/DSA.
* Age ≥18 and ≤80
* No significant pre-stroke functional disability (mRS ≤ 1)
* The possibility to start treatment within 6 hours from onset.
* Informed consent given
Exclusion Criteria:
* Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0
* Baseline platelet count \< 50.000/µL
* Baseline blood glucose of \< 50mg/dL or \>400mg/dl
* Severe, sustained hypertension (SBP \> 220 mm Hg or DBP \> 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained below these levels using commonly used medications in China for these purposes (including iv antihypertensive drips), the patient can be enrolled.
* Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
* History of life threatening allergy (more than rash) to contrast medium
* Subjects who has received iv t-PA treatment beyond 4.5 hours from the beginning of the symptoms.
* Patients with acute stroke within the first 48 hours after percutaneous cardiac, cerebrovascular interventions and major surgery
* Renal insufficiency with creatinine ≥ 3 mg/dl
* Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.
* Subject participating in a study involving an investigational drug or device that would impact this study.
* Cerebral vasculitis
* Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, mRS score at baseline must be ≤ 1, which includes 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.)
* Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas).
* CT or MR evidence of hemorrhage (the presence of microbleeds on MRI is allowed).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03163459
Study Brief:
Protocol Section:
NCT03163459