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 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT03876457
Eligibility Criteria:
Inclusion Criteria:
1. Adults (18-85 years) with the final diagnosis of an acute ischemic stroke
2. NIH Stroke Scale Score (NIHSS) ≥ 6
3. Last known well to groin puncture or medical management between 0 to 24 hours
4. Pre-stroke modified Rankin Scale score (mRS) of 0-1
5. Eligible for thrombectomy or medical management
6. Signed Informed Consent obtained
7. Subject willing to comply with the protocol follow-up requirements
8. Anticipated life expectancy of at least 3 months
Specific Neuroimaging Inclusion Criteria:
1. Proven large vessel occlusion in ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial, with or without tandem MCA lesions) determined by MRA or CTA
2. Large infarct-core lesion on at least one of the following:
* 2.1. Non-Contrast CT (ASPECTS of 3-5),
* 2.2. CT perfusion (rCBF\<30% ≥50cc),
* 2.3. MRI-DWI (ADC\<620 ≥50cc)
Exclusion Criteria:
1. Inability to undergo CT angiography and/or CT perfusion imaging (e.g., renal insufficiency, iodine/contrast allergy)
2. Co-morbid psychiatric or medical illnesses that would confound the neurological assessments
3. Treatment with thrombolytic agent beyond 4.5 hours from last known well
4. Treated with thrombolytic agent 3-4.5 hours after last known well AND any of the following:
* 1\) age \>80,
* 2\) current anticoagulant use,
* 3\) history of diabetes AND prior stroke,
* 4\) NIHSS \>25,
* 5\) ischemic involvement of \> 1/3 MCA territory
5. Current participation in another investigational drug or device study.
Neuroimaging Exclusion Criteria
1. Patients who have both ASPECTS of 6-10 on non-contrast CT AND core volume \<50 cc on perfusion imaging
2. Patients with very large core on non-contrast CT i.e. ASPECTS ≤ 2
3. Evidence of intracranial tumor (except small meningioma), acute intracranial hemorrhage, neoplasm, or arteriovenous malformation
4. A significant mass effect with midline shift
5. Evidence of internal carotid artery dissection that is flow limiting or aortic dissection
6. Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device
7. Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion).
8. Signs of established infarct and large area of cerebral edema on non-contrast CT
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03876457
Study Brief:
Protocol Section:
NCT03876457