Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The primary objective of the trial is to establish the effectiveness of IAT (versus medical
management) in patients with moderate-large infarcts (NCCT ASPECTS 2-5) at baseline, with
adaptive enrichment to better define the upper limit of infarct volume for treatment
eligibility. Furthermore, the investigators aim to determine whether certain subgroups of
patients with large baseline infarcts will have a greater treatment benefit. Finally, the
investigators will assess the agreement of ASPECTS scores between site investigators, the
core imaging lab, and automated software.
Phase
N/A
Funding Agency/Sponsor
Other
Disease
Stroke
Enrollment Eligibility
Inclusion Criteria:
1. 18 to 85 years of age
2. Presenting with symptoms consistent with an acute ischemic stroke
3. Imaging evidence of an anterior circulation occlusion of the Internal Carotid Artery
(ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1) segment
4. NIHSS score >6 at the time of randomization
5. Ability to randomize within 24 hours of stroke onset
6. Pre-stroke mRS score 0-1
7. Ability to obtain signed informed consent
Imaging evidence of moderate-large infarct defined as:
1. NCCT ASPECTS 2-5
Exclusion Criteria:
1. Females who are pregnant, or those of child-bearing potential with positive urine or
serum beta Human Chorionic Gonadotropin (HCG) test
2. Known severe allergy (more than a rash) to contrast media uncontrolled by medications
3. Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or
diastolic blood pressure >110 mmHg)
4. CT evidence of the following conditions:
- Midline shift or herniation
- Evidence of intracranial hemorrhage
- Mass effect with effacement of the ventricles
5. Computed Tomography Angiography (CTA) evidence suggestive of difficult endovascular
access per the treating interventionalist
6. Presence of cervical ICA occlusion (e.g., related to atherosclerotic disease or
dissection)
7. Rapidly improving neurological status prior to randomization to NIHSS <6
8. Bilateral strokes or multiple intracranial occlusions
9. Intracranial tumors
10. Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant
therapy with an International Normalized Ratio (INR) of >3.0 or Partial Thromboplastin
Time (PTT) >3 times of normal
11. Baseline platelet count <30,000 per microliter (µl)
12. Life expectancy less than 90 days prior to stroke onset
13. Participation in another randomized clinical trial that could confound the evaluation
of the study
14. Any other condition (in the opinion of the site investigator) that precludes an
endovascular procedure or poses a significant hazard to the patient if an endovascular
procedure was performed