Table 2. Core laboratory-adjudicated reperfusion endpoints and clinical outcomes in intention-to-treat and modified intention-to-treat populations.
| Parameter | mITT (n=107)* | ITT/safety (n=139) |
| Primary effectiveness endpoint | ||
| Successful reperfusion (eTICI 2b–3) within three NeVa passes without rescue, n (%) | 97 (90.7%) | 125 (89.9%) |
| 95% Wilson Score CI | (83.6%, 94.8%) | (83.8%, 93.9%) |
| Secondary angiographic endpoints | ||
| Successful reperfusion (eTICI 2b–3) after first pass, n (%) | 79 (73.8%) | 95 (68.3%) |
| Excellent reperfusion (eTICI 2c–3) after first pass, n (%) | 52 (48.6%) | 65 (46.8%) |
| Successful reperfusion (eTICI 2b–3) after all passes without rescue, n (%) | 102 (95.3%) | 132 (95.0%) |
| Excellent reperfusion (eTICI 2c–3) after all passes without rescue, n (%) | 76 (71.0%) | 104 (74.8%) |
| eTICI outcomes within three passes without rescue | ||
| eTICI 2c–3 within three passes without rescue, n (%) | 73 (68.2%) | 100 (71.9%) |
| eTICI 2b67–3 within three passes without rescue, n (%) | 89 (83.2%) | 117 (84.2%) |
| 0: No flow | 6 (5.6%) | 8 (5.8%) |
| 1: Penetration, but not distal branch filling | 0 (0.0%) | 0 (0.0%) |
| 2a: Partial reperfusion with incomplete (< 50%) or slow distal branch filling | 4 (3.7%) | 6 (4.3%) |
| 2b50: Reperfusion of 50–66% of the territory | 8 (7.5%) | 8 (5.8%) |
| 2b67: Reperfusion of 67–89% of the territory | 16 (15.0%) | 17 (12.2%) |
| 2c: Reperfusion of 90–99% of the territory | 32 (29.9%) | 43 (30.9%) |
| 3: Complete or 100% reperfusion | 41 (38.3%) | 57 (41.0%) |
| Other angiographic outcomes | ||
| eTICI 2b67–3 after first pass, n (%) | 74 (69.2%) | 89 (64.0%) |
| eTICI 3 after first pass, n (%) | 33 (30.8%) | 42 (30.2%) |
| Use of rescue therapy†, n (%) | 4 (3.7%) | 5 (3.6%) |
| Final eTICI 2b-3 including rescue, n (%) | 106 (99.1%) | 137 (98.6%) |
| Final eTICI 2b67–3 including rescue, n (%) | 98 (91.6%) | 126 (90.6%) |
| Final eTICI 2c–3 including rescue, n (%) | 78 (72.9%) | 106 (76.3%) |
| Final eTICI grade with rescue | ||
| 0: No flow | 0 (0.0%) | 0 (0.0%) |
| 1: Penetration, but not distal branch filling | 0 (0.0%) | 0 (0.0%) |
| 2a: Partial reperfusion with incomplete (< 50%) or slow distal branch filling | 1 (0.9%) | 2 (1.4%) |
| 2b50: Reperfusion of 50–66% of the territory | 8 (7.5%) | 11 (7.9%) |
| 2b67: Reperfusion of 67–89% of the territory | 20 (18.7%) | 20 (14.4%) |
| 2c: Reperfusion of 90–99% of the territory | 34 (31.8%) | 45 (32.4%) |
| 3: Complete or 100% reperfusion | 44 (41.1%) | 61 (43.9%) |
| Time from arterial puncture to first device pass (min), median (IQR) | 18 (11–25) | 18 (11–25) |
| Procedure duration (min), median (IQR) | 32 (20–51) | 35 (22–52) |
| Number of passes, median (IQR) | 1 (1−2) | 1 (1−2) |
| Secondary clinical endpoint | ||
| 90-day good outcome (mRS score 0–2), n (%) | 69/106 (65.1%) | 87/138 (63.0%) |
| 95% Wilson Score CI | (55%, 74%) | (54%, 71%) |
| Other clinical outcomes | ||
| NIHSS score at 24 hours, median (IQR) | 4 (1−8) | 4 (1−10) |
| NIHSS score change from baseline to 24 hours, median (IQR) | −10 (−15 to −5) | −9 (−15 to −5) |
| NIHSS score at earlier of 5–10 days or discharge, median (IQR) | 2 (0–5) | 2 (0–6) |
| NIHSS score change from baseline to 5–10 days or discharge, median (IQR) | −11 (−17 to −8) | −11 (−17 to −7) |
*
mITT was the primary effectiveness population.
†
Rescue therapy is defined as when the initial target vessel occlusion required treatment with an approved non-NeVa stent retriever or direct aspiration catheter.
eTICI expanded Treatment in Cerebral Ischemia; ITT, intention-to-treat population; mITT, modified intention-to-treat population; mRS, modified Rankin Scale score; NIHSS, National Institutes of Health Stroke Scale