Background We describe the first-in-human experience using the Route 92 Medical Aspiration System to perform thrombectomy in the initial 45 consecutive stroke patients enrolled in the SUMMIT NZ trial. This aspiration system includes a specifically designed delivery catheter which enables delivery of 0.070 inch and 0.088 inch aspiration catheters.
Methods The SUMMIT NZ trial is a prospective, multicenter, single-arm study with core lab imaging adjudication. Patients presenting with acute ischemic stroke from large vessel occlusion are eligible to enrol. The study has had three phases which transitioned from use of the 0.070 inch to the 0.088 inch catheter.
Results Vessel occlusions were located in the internal carotid artery (27%), M1 (60%) and M2 (13%). Median baseline National Institutes of Health Stroke Scale (NIHSS) was 16 (IQR 10). Across the three phases, the first-pass reperfusion rate of modified Thrombolysis In Cerebral Infarction (mTICI) ≥2b was 62% using the Route 92 Medical system; this rate was 29% in phase 1, 56% in phase 2, and 80% in phase 3. The first-pass reperfusion rate of mTICI ≥2c was 42% overall, 29% in phase 1, 33% in phase 2, and 55% in phase 3. A final reperfusion rate of mTICI ≥2b was achieved in 96% of cases, with 36% of cases using adjunctive devices. Patients had an average improvement of 6.7 points in NIHSS from baseline at 24 hours, and at 90 days 48% were functionally independent (modified Rankin Scale 0–2).
Conclusions In this early experience, the Route 92 Medical Aspiration System has been effective and safe. The system has design features that improve catheter deliverability and have the potential to increase first-pass reperfusion rates in aspiration thrombectomy.
Data availability statement
Data are available upon reasonable request. Trial data is available from the corresponding author on reasonable request.
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Correction notice This article has been corrected since it first published. In the Abstract, 'phase 2%' has been corrected to 'phase 2'.
Contributors The manuscript was drafted by JC, reviewed by all authors and edited by SH, DL, AH, PAB, SB, TW, WC and BM. Figures were arranged by SL and JC. Figure 1 was produced by medical illustrator Mark Lefkowitz for Route 92 Medical who provided it for use in this manuscript. The images for Figure 2 were provided by Route 92 Medical and arranged by SL. Revisions were made and edited by JC, BM and PAB and reviewed by all authors. JC is the guarantor.
Funding This study was funded by Route 92 Medical (N/A).
Competing interests The study investigators were not remunerated for their involvement in this study or the production of the manuscript. Dr Brew, Dr McGuinness, Dr Caldwell and Dr Lee have consulting agreements with Route 92 Medical.
Provenance and peer review Not commissioned; externally peer reviewed.
Addendum Route 92 Medical, Tenzing & Base Camp are registered trademarks of Route 92 Medical Inc (San Mateo, CA). T7, Hipoint, and Monopoint are trademarks of Route 92 Medical, Inc (San Mateo, CA).
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