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 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT06634303
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 to 89
2. Informed signed consent obtained from patient or legally authorized representative
3. Clinical symptoms consistent with acute ischemic stroke
4. Pre-stroke modified Rankin Scale (mRS) score 0-1
5. National Institute of Health Stroke Scale (NIHSS) ≥ 6
6. Alberta Stroke Program Early CT Score (ASPECTS) score 5-10
7. IV tissue plasminogen activator (tPA) or Tenecteplase (TNK) may be administered within 4.5h of last known well (LKW), if patient eligible
8. Mechanical thrombectomy (MT) treatment performed with arterial puncture within 24h of LKW.
9. Pre-MT catheter angiogram shows target occlusion in intracranial ICA, M1 MCA, or M2 MCA
10. End of MT catheter angiogram shows achievement of moderate-to-complete reperfusion (modified Treatment in Cerebral Ischemia score or mTICI 2a-3)
Exclusion Criteria:
1. Pre-MT CT or MRI shows acute intracranial hemorrhage.
2. Previous intracranial hemorrhage, AVM, neoplasm (except small meningioma), or vascular stent-implant
3. Coma or reduced level of consciousness prior to MT (NIHSS 1A\>1)
4. Seizure between LKW and time of potential enrollment
5. Severe contrast allergy or absolute contraindication to iodinated contrast.
6. Hypersensitivity to cold, i.e., history of cold-sensitive antibodies, Raynaud syndrome, or hepatitis C
7. Hematocrit \<33%
8. Severe known renal impairment, i.e., requires renal replacement therapy (dialysis).
9. Post-reperfusion investigational therapy cannot be started within 150 min following pre-treatment CT or MR imaging
10. Presumed septic embolism, suspicion of bacterial endocarditis.
11. Known pregnancy (in women with child-bearing potential)
12. Body weight \< 40kg
13. Patient not willing and able to participate in follow-up visits to day 90.
14. Life expectancy \<6 months due to pre-existing conditions such as severe heart or renal failure, cancer, etc.
15. Currently or within past 30 days participating in another investigational treatment study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT06634303
Study Brief:
Protocol Section:
NCT06634303