Patient demographics and baseline characteristics
| Category | mITT analysis set N=100 | Safety analysis set N=102 |
| Age at consent, years (mean±SD) | 70.4±14.0 | 70.6±13.9 |
| Female, n/N (%) | 59/100 (59.0%) | 61/102 (59.8%) |
| Medical history, n/N (%) | ||
| Hypertension | 65/100 (65.0%) | 65/102 (63.7%) |
| Atrial fibrillation | 43/100 (43.0%) | 43/102 (42.2%) |
| Hyperlipidemia | 25/100 (25.0%) | 25/102 (24.5%) |
| Diabetes | 13/100 (13.0%) | 13/102 (12.7%) |
| History of ischemic stroke | 12/100 (12.0%) | 12/102 (11.8%) |
| Smoking (active) | 12/100 (12.0%) | 12/102 (11.8%) |
| CAD | 8/100 (8.0%) | 8/102 (7.8%) |
| Smoking (previous) | 8/100 (8.0%) | 8/102 (7.8%) |
| Myocardial Infarction | 7/100 (7.0%) | 7/102 (6.9%) |
| Congestive heart failure | 6/100 (6.0%) | 6/102 (5.9%) |
| Previous CABG | 5/100 (5.0%) | 5/102 (4.9%) |
| Previous coronary intervention | 5/100 (5.0%) | 5/102 (4.9%) |
| DVT | 4/100 (4.0%) | 4/102 (3.9%) |
| COPD | 3/100 (3.0%) | 3/102 (2.9%) |
| History of TIA | 3/100 (3.0%) | 3/102 (2.9%) |
| History of hemorrhagic stroke | 2/100 (2.0%) | 2/102 (2.0%) |
| Current drug abuse (cocaine, amphetamine) | 1/100 (1.0%) | 1/102 (1.0%) |
| Previous CEA | 1/100 (1.0%) | 1/102 (1.0%) |
| Pre-stroke mRS, n/N (%) | ||
| 0 | 79/100 (79.0%) | 80/102 (78.4%) |
| 1 | 19/100 (19.0%) | 20/102 (19.6%) |
| 2 | 1/100 (1.0%) | 1/102 (1.0%) |
| 4 | 1/100 (1.0%) | 1/102 (1.0%) |
| Baseline NIHSS total score, n/N (%) | ||
| <8 | 14/100 (14.0%) | 15/102 (14.7%) |
| ≥8 | 86/100 (86.0%) | 87/102 (85.3%) |
| Baseline NIHSS total score | ||
| Mean±SD | 14.9±6.4 | 14.8±6.4 |
| Median (IQR) | 16.0 (10.5–19.5) | 16.0 (9.0–19.0) |
| Baseline stroke, n/N (%) | ||
| Witnessed stroke with onset date/time known | 72/100 (72.0%) | 74/102 (72.5%) |
| Wake-up stroke | 9/100 (9.0%) | 9/102 (8.8%) |
| Unwitnessed non-wake up stroke | 19/100 (19.0%) | 19/102 (18.6%) |
| Use of IV-tPA for baseline stroke, n/N (%) | 51/100 (51.0%) | 53/102 (52.0%) |
| Baseline ASPECT score* n/N (%) | ||
| 0 | 0/100 (0.0%) | 0/102 (0.0%) |
| 1 | 1/100 (1.0%) | 1/102 (1.0%) |
| 2 | 2/100 (2.0%) | 2/102 (2.0%) |
| 3 | 3/100 (3.0%) | 3/102 (2.9%) |
| 4 | 2/100 (2.0%) | 2/102 (2.0%) |
| 5 | 7/100 (7.0%) | 7/102 (6.9%) |
| 6 | 10/100 (10.0%) | 10/102 (9.8%) |
| 7 | 15/100 (15.0%) | 15/102 (14.7%) |
| 8 | 22/100 (22.0%) | 23/102 (22.5%) |
| 9 | 16/100 (16.0%) | 17/102 (16.7%) |
| 10 | 22/100 (22.0%) | 22/102 (21.6%) |
| Baseline (pre-procedure) anterior occlusion location* | 100/100 (100.0%) | 102/102 (100.0%) |
| ICA/carotid T | 21/100 (21.0%) | 21/102 (20.6%) |
| MCA | 74/100 (74.0%) | 76/102 (74.5%) |
| M1 | 71/100 (71.0%) | 73/102 (71.6%) |
| M2 | 3/100 (3.0%) | 3/102 (2.9%) |
| ACA | 1/100 (1.0%) | 1/102 (1.0%) |
| Other | 3/100 (3.0%) | 3/102 (2.9%) |
| Cannot determine | 2/100 (2.0%) | 2/102 (2.0%) |
*Assessments made by the independent imaging core lab.
ACA, anterior cerebral artery; ASPECTS, Alberta Stroke Program Early CT Score; CABG, coronary artery bypass grafting; CAD, coronary artery disease; CAS, carotid artery stenting; CEA, carotid artery endarterectomy; COPD, chronic obstructive pulmonary disease; DVT, deep vein thrombosis; ICA, internal carotid artery; IV-tPA, intravenous tissue plasminogen activator; MCA, middle cerebral artery; mITT, modified intent-to-treat; mRS, modified Rankin scale; NIHSS, National Institutes of Health Stroke Scale; TIA, transient ischemic attack.