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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT03731351
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 - 85.
2. Clinical signs consistent with acute ischemic stroke.
3. No prestroke functional dependence (prestroke Modified Rankin Score ≤ 1).
4. NIHSS \<6 at the time of enrollment.
5. Consent obtained within 24 hours from last known well.
6. Thrombolysis in Cerebral Infarction (TICI) 0-1 flow in
1. The M1 or M2 segment of the MCA, or carotid terminus confirmed by CT or MR angiography; or
2. The basilar artery.
7. Subject can be treated within 1 hours (60 minutes) from pre-procedure CT or MRI to groin puncture.
8. CT or MRI-DWI ASPECT Score of \> 6 in the anterior circulation, or posterior circulation ASPECT Score (pc-ASPECTS) of \> 7.36
9. Subject is willing to conduct protocol-required follow-up visits.
10. Subject or subject's legally authorized representative has signed and dated an Informed Consent Form.
NB: Patient can be enrolled regardless of whether the patient received IV t-PA. However, the decision for administration of IV t-PA must be made before enrolling into the study.
Exclusion Criteria:
1. Female who is pregnant or lactating or has a positive pregnancy test at time of admission.
2. Known serious sensitivity to radiographic contrast agents.
3. Subject with a pre-existing neurological or psychiatric disease that would confound the neurological and functional evaluations. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of hemorrhage on presentation.
4. CT or MRI ASPECT score of ≤6 in the anterior circulation, or pc-ASPECTS of ≤7.
5. CT or MRI evidence of mass effect or intra-cranial tumor (except small meningioma).
6. Current participation in another investigation drug or device treatment study.
7. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency.
8. Warfarin therapy with INR greater than 1.7.
9. Low molecular Weight Heparins, Heparin, Factor Xa inhibitors or direct thrombin inhibitors as full dose within the last 48 hours from screening and must have a normal partial thromboplastin time (PTT) to be eligible.
10. Baseline lab values: glucose \< 50 mg/dL or \> 400 mg/dL, platelets \< 100,000 or Hct \< 25.
11. Renal Failure as defined by a serum creatinine \> 2.0 or Glomerular Filtration Rate \[GFR\]\< 30.
12. Life expectancy of less than 90 days.
13. Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal.
14. Presumed septic embolus, or suspicion of bacterial endocarditis.
15. Preprocedural or intraprocedural diagnosis of an unexpected vascular lesion or condition that may require additional, non-standard thrombectomy endovascular procedure(s), such as stenting, angioplasty or other treatment, and pose an additional or elevated risk. Such conditions, listed below, exclude or invalidate enrollment in the study:
1. Previous intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, cerebral aneurysm, or arteriovenous malformation
2. Previously unknown dissection, vasculitis, vasculopathy, severe hemodynamically significant vascular stenosis, or other atypical vascular lesion
3. Tandem lesions, defined as an occlusion involving both the cervical and intracranial segment of the same vascular distribution
4. Stroke or vascular occlusions in multiple vascular territories
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03731351
Study Brief:
Protocol Section:
NCT03731351