Intra-arterial Tenecteplase for Acute Medium Vessel Occlusion Stroke
Status:
NOT_YET_RECRUITING
Trial end date:
2027-12-31
Target enrollment:
Participant gender:
Summary
The ANGEL-MeVO-TNK is a multicentered, prospective, randomized, open label, blinded endpoint (PROBE) phase III trial. A total of 488 AIS patients (age 18 years) with acute MeVO-AIS (occlusion of the M2/M3, the A1/A2/A3, the P1/P2/P3, and with baseline NIHSS score \>5 or disabling stroke with NIHSS score 3-5 \[such as neurological deficits in motor strength, language, vision, etc\]), will be enrolled. Patients fulfilling all the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into the IA TNK group or the control group after offering informed content.
* The IA TNK group will receive IA TNK (0.2-0.3 mg/min, for 15 -30min), be infused slowly.
* The control group will be given standard medical management.
The study consists of four visits including the day of randomization, 4812 hours after randomization, and 907 days after randomization. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program.
The primary outcome is the modified Rankin Scale (mRS) score of 0 to 1 at 907 days after onset. The primary safety outcome is the incidence of sICH within 4812 hours after randomization (ECASS III).