Robot-Assisted Hematoma Evacuation With Intrahematoma Tenecteplase for Post-Reperfusion PH2 Hemorrhagic Transformation

Summary

The purpose of this phase I trial is to evaluate the safety and feasibility of robot-assisted stereotactic minimally invasive hematoma aspiration, followed when eligible by intrahematoma tenecteplase administration, in patients who develop symptomatic supratentorial PH2 hemorrhagic transformation after reperfusion therapy for acute ischemic stroke. The main study questions are whether this strategy is associated with an acceptable early rebleeding risk and whether it can achieve clinically meaningful hematoma reduction with accurate catheter placement and relief of hematoma-related mass effect.

Timeline

Start

2026-06-10

Primary completion

2026-12-10

Completion

2026-12-30

Publications

• Background Ha HJ, Ryu WS, Sunwoo L, Lee M, Kang K, Kim JG, Lee SJ, Cha JK, Park TH, Lee JY, Lee K, Kwon DH, Lee J, Park HK, Hong KS, Lee M, Oh MS, Yu KH, Gwak DS, Kim DE, Kim H, Kim JT, Kim JG, Choi JC, Kim WJ, Weon YC, Kwon JH, Yum KS, Shin DI, Hong JH, Sohn SI, Lee SH, Kim C, Jeong HB, Park KY, Kim CK, Kang J, Kim JY, Bae HJ, Lin L, Parsons M, Kim BJ. Clinical Impact of Postrecanalization Hemorrhagic Transformation and Its Prediction Using Baseline Noncontrast CT. Stroke. 2026 May;57(5):1325-1335. doi: 10.1161/STROKEAHA.125.053938. Epub 2026 Mar 9.
• Background Wu Z, Wang M, Bai X, Tang J, Ni Y, Zhao S, Wang P, He Q, Huo R, Jiao Y, Wang D, Cao Y. Phase I dose-escalation study of tenecteplase, a third-generation fibrinolytic agent, combined with neuronavigation-assisted stereotactic minimally invasive puncture, in patients with acute spontaneous deep cerebral haemorrhage. Stroke Vasc Neurol. 2026 Jun 29;11(3):296-302. doi: 10.1136/svn-2025-004389.
• Background Hanley DF, Thompson RE, Rosenblum M, Yenokyan G, Lane K, McBee N, Mayo SW, Bistran-Hall AJ, Gandhi D, Mould WA, Ullman N, Ali H, Carhuapoma JR, Kase CS, Lees KR, Dawson J, Wilson A, Betz JF, Sugar EA, Hao Y, Avadhani R, Caron JL, Harrigan MR, Carlson AP, Bulters D, LeDoux D, Huang J, Cobb C, Gupta G, Kitagawa R, Chicoine MR, Patel H, Dodd R, Camarata PJ, Wolfe S, Stadnik A, Money PL, Mitchell P, Sarabia R, Harnof S, Barzo P, Unterberg A, Teitelbaum JS, Wang W, Anderson CS, Mendelow AD, Gregson B, Janis S, Vespa P, Ziai W, Zuccarello M, Awad IA; MISTIE III Investigators. Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial. Lancet. 2019 Mar 9;393(10175):1021-1032. doi: 10.1016/S0140-6736(19)30195-3. Epub 2019 Feb 7.
• Background Zhou X, Chen J, Li Q, Ren G, Yao G, Liu M, Dong Q, Guo J, Li L, Guo J, Xie P. Minimally invasive surgery for spontaneous supratentorial intracerebral hemorrhage: a meta-analysis of randomized controlled trials. Stroke. 2012 Nov;43(11):2923-30. doi: 10.1161/STROKEAHA.112.667535. Epub 2012 Sep 18.

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Indications