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Trial Design Baseline Recanalization Rates Good Clinical Outcome Mortality SICH NIHSS (90-day mRS ≤ 2) Rx Ctrl Rx Ctrl Rx Ctrl Rx Ctrl Rx Ctrl PROACT II*(n = 180) (IAT, 121) RCT, IA pro-UK + IV heparin vs IV heparin 17 17 66% 18% 40% 25% 25% 27% 10% 2% MELT Japan† (n = 114), (IAT, 57) RCT, IA UK vs medical treatment 14 14 73.7% – 49.1% 38.6% 5.3% 3.5% 9% 2% IMS I (n = 80), (IAT, 62) POL, IV rtPA + IA rtPA 18 – 56% – 43% – 16% – 6.3% – IMS II (n = 81) (IAT, 55) POL, IV rtPA + IA rtPA/EKOS 19 – 58% – 46% – 16% – 9.9% MERCI (n = 141) POL, IA MERCI, IA lytics allowed, IV disallowed 20 – 60.3% – 27.7% – 43.5% – 7.8% – 48%‡ Multi MERCI (n = 164) POL, IA MERCI, IA + IV lytics allowed 19 – 68% – 36% – 34% – 9.8%, PH-2: 2.4% – 55%‡ Penumbra (n = 125) POL, IA Penumbra, IA lytics allowed 17 – 81.6%‡ – 25% – 32.8% – 11.2%, PH-2: 1.6% – Note:—Rx indicates treatment; Ctrl, control; RCT, randomized controlled trial; EKOS, EKOS MicroLysUS infusion catheter; PH, parenchymal hematoma; POL, prospective open-label study; IAT: number of patients treated with IAT; NIHSS, National Institutes of Health Stroke Scale; mRS, modified Rankin Scale; SICH, symptomatic intracranial hemorrhage; IA, intra-arterial; IV, intravenous; UK, urokinase; rtPA, recombinant tissue plasminogen activator.
* Primary end point (90-day mRS ≤2) was reached (P = .04).
† Secondary end point (90-day mRS ≤1) was reached (42.1% vs 22.8%, P = .045).
‡ Device alone.
Trial and Clinical Outcomes at 90 days Recanalized Patients (%) Nonrecanalized Patients (%) P Value MERCI mRS ≤2 46 10.4 <.0001 Mortality 31.8 54.2 .0101 Multi MERCI mRS ≤2 49.1 9.6 <.001 Mortality 24.8 51.9 <.001 Penumbra mRS ≤2 29 9 .0596 Mortality 29 48 .1384 IMS I-II mRS ≤2 45.6 6.9 .0004 Mortality 10.9% 34.5 .01