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 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT00810095
Eligibility Criteria:
Inclusion Criteria:
1. NIHSS 6 to 30 within 6 hours of symptom onset
2. Pre-stroke Modified Rankin Score ≤ 2
3. Large Vessel Occlusion
4. Patient/patient guardian is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluation.
5. Patients must meet at least one of the following criteria:
* Eligible for Intravenous rt-PA
* Eligible for Intra-arterial rt-PA - IA rt-PA initiated within 6 hours of symptom onset
* Patient presents within 6 hours of symptom onset
Exclusion Criteria:
1. Pregnancy
2. Glucose \<50mg/dL
3. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR\>3.0
4. Patient received heparin within 48 hours with a PTT greater than 2 times the lab normal.
5. Patient has baseline platelets \< 30,000
6. Evidence of rapidly improving neurological signs of stroke at time of enrollment
7. Coma
8. Pre-existing neurological or psychiatric disease that could confound the study results
9. Known severe allergy to contrast media or nitinol
10. Patient has severe sustained hypertension
11. CT/MRI scan reveals significant mass effect with midline shift
12. Patient's angiogram shows an arterial stenosis \>50% proximal to the embolus.
13. Patient's anticipated life expectancy is less than 3 months
14. Participation in another clinical investigation that could confound the evaluation of the study device
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00810095
Study Brief:
Protocol Section:
NCT00810095