Article Figures & Data
Figures
- Figure 1
Illustration of the Catfish stent-retriever device. (A) The thinner strut of the proximal-third segment and distal-third segment which was equal to 0.7-fold diameter of strut at middle-third segment, three distal radio-opaque markers. A2: large clot catching cell. A3: radiopaque platinum wire integration into the stent strut. A4: One Proximal radio-opaque marker. (B) The Catfish (B2) have a larger stent cells compared to the competitive stent (B1). (C) The Catfish have a optimal coverage and wall apposition peculiarity in tortuous anatomical model. (D) Fluoroscopic visibility of the deployed Catfish stent retriever device.
- Figure 2
Trial profile. mRS, modified Rankin scale; NIHSS, National Institutes of Health Stroke Scale.
- Figure 3
Treatment outcomes. (A) Immediately mTICI grade after first pass thrombectomy; (B) mTICI grade at the end of the procedure, the successful recanalisation rate at the end of the precedure in the Catfish group was non-inferior to that in the Solitaire group for per-protocol population analysis (rate difference, 0.83; 95% CI –7.03 to 8.70;). (C) and (D) Modified Rankin Scale at 3 months. mTICI, modified thrombolysis in cerebral infarction.
- Figure 4
Categorised whisker plots of mean NIHSS scores at admission, at 24 hours, and at 7 days or discharge in both groups. NIHSS, National Institutes of Health Stroke Scale.
Tables
- Table 1
Baseline clinicodemographic features
Catfish group
(n=113)Solitaire group
(n=114)Age (years) 62.0 (13.2) 62.2 (12.4) Male 59 (52.2) 72 (63.2) NIHSS score Mean (SD) 15.9 (4.6) 15.1 (4.3) Median (range) 16 (12–20) 16 (12–20) Pre-stroke mRS score 0 98 (86.7) 104 (91.2) 1 15 (13.3) 9 (7.9) 2 0 0 3 0 0 4 1 (0.4) 0 Intravenous t–PA pre-procedure 46 (40.7) 46 (40.3) Medical history Hypertension 68 (60.2) 69 (60.5) Diabetes mellitus 11 (9.7) 13 (11.4) Hyperlipidaemia 9 (8.0) 7 (6.1) Atrial fibrillation 45 (39.8) 40 (35.1) Ischaemic stroke or transient ischaemic attack 21 (18.6) 25 (21.9) Myocardial infarction or coronary artery disease 23 (20.4) 25 (21.9) Admission systolic blood pressure, mm Hg 142.8 (20.4) 144.1 (20.9) Admission diastolic blood pressure, mm Hg 82.1 (12.1) 82.9 (13.7) Baseline ASPECT score Mean (SD) 8.1 (1.3) 8.1 (1.29) Median (range) 8 (7–9) 8 (7–9) Baseline pc–ASPECT score Mean (SD) 9.88 (0.6) 9.56 (1.7) Median (range) 10 (10–10) 10 (10–10) Site of occlusion Internal carotid artery (ICA) 30 (26.6) 34 (30.1) Anterior cerebral artery 3 (2.7) 1 (0.9) Middle cerebral artery M1 58 (51.3) 67 (59.3) M2 13 (11.5) 6 (5.3) Posterior circulation V4 2 (1.8) 0 (0) Basilar artery 3 (2.7) 4 (3.5) Posterior cerebral artery 1 (0.9) 0 (0) Other Tandem cervical ICA 3 (2.7) 1 (0.9) Onset to main hospital arrival, min 195 (115–240) 170 (114–240) Data are mean (SD), n (%) or median (IQR).
ASPECT, Alberta stroke program early CT score; M1, first segment of the middle cerebral artery; M2, second segment of the middle cerebral artery; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; pc–ASPECT, Posterior circulation–Alberta stroke programme early CT score; tPA, alteplase; V4, fourth segment of the vertebral artery.
- Table 2
Efficacy endpoints and procedure details
Catfish group (n=113) Solitaire group (n=114) Rate difference
(95% CI)Non-inferiority P value Primary efficacy endpoint Successful recanalisation at the end of the procedure Per-treatment 100 (88.5) 100 (87.7) 0.78 (–7.64 to 9.20) 0.001 Per-protocol 98 (90.7; n=108) 98 (89.9; n=109) 0.83 (–7.03 to 8.70) <0.001 Secondary efficacy endpoints Time from arterial puncture to final reperfusion, min 81.6 (46.2) 82.2 (58.8) NA NA mTICI 2b/3 after first pass 58 (51.8; n=112) 61 (54.0; n=113) NA NA 2b 16 (14.2) 27 (23.9) NA NA 3 42 (37.5) 34 (30.0) NA NA Successful recanalisation with study device Per-treatment 87 (88.8; n=98) 85 (89.5; n=95) –0.70 (–9.48 to 8.08) 0.004 Per-protocol 86 (91.5; n=94) 84 (92.3; n=91) –0.82 (–8.68 to 7.04) 0.002 Use of rescue treatment NA NA Balloon angioplasty 8 (53.3; n=15) 7 (36.8; n=19) Stent implantation 4 (26.7; n=15) 9 (47.4; n=19) Balloon angioplasty+stent implantation 3 (20.0; n=15) 3 (15.8; n=19) NIHSS score at 24 hours 15.8 (11.3; n=109) 13.8 (9.3; n=111) NA NA NIHSS score at 7 days 13.4 (12.0; n=111) 11.5 (10.3; n=113) NA NA Good neurological outcome at 90 days (mRS score of 0–2) Per-treatment 54 (47.8) 57 (50.0) NA NA Per–protocol 53 (49.1; n=108) 55 (50.5; n=109) NA NA Data are mean (SD), n (%) or median (IQR).
The successful recanalisation rate after procedure completion in the Catfish group was non-inferior to that of the Solitaire group for per-treatment analysis; the common OR was 0.78 (95% CI, –7.64 to 9.20; p=0.001).
mRS, modified Rankin Scale; mTICI, modified thrombolysis in cerebral infarction; NIHSS, National Institutes of Health Stroke Scale; Per-protocol, per-protocol analysis; Per-treatment, per-treatment analysis.
- Table 3
Safety endpoints
Catfish group (n=113) Solitaire group (n=114) Serious adverse events Study device-associated 15 (13.3) 12 (10.5) Procedure-associated Local puncture site haematoma 0 1 (0.9) Embolisation in a new vascular territory 1 (0.9) 3 (2.6) Arterial perforation 2 (1.8) 1 (0.9) Vasospasm 17 (15.0) 9 (7.9) Subarachnoid haemorrhage 5 (4.4) 4 (3.5) Symptomatic haemorrhage 9 (8.0) 9 (7.9) All-cause death by 90 days 20 (17.7) 18 (15.8) Data are n (%).
