NCT07357987

Intra-arterial Tenecteplase for Acute Medium Vessel Occlusion Stroke

Intra-arterial Tenecteplase for Acute Medium Vessel Occlusion Stroke: the ANGEL-MeVO-TNK Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 488 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, 48±12 hours after randomization, and 90±7 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 90±7 days after onset. The primary safety outcome is the incidence of sICH within 48±12 hours after randomization (ECASS III).

Conditions

• Ischemic Stroke
• Medium Vessel Occlusion
• Tenecteplase
• Endovascular Treatment

Interventions

Type	Name	Description
PROCEDURE	Intra-arterial Tenecteplase	1. If the patient has not received IVT, IA TNK will be administered as a slow, continuous infusion at a rate of 0.2-0.3 mg/min for super-selective contact thrombolysis, with a duration of 15-30 minutes. A repeat angiogram will be performed 15 minutes after the start of infusion to assess vessel recanalization, and the operator may decide whether to continue drug administration based on the angiographic findings. 2. If the patient has received IVT, intra-arterial TNK will be administered as a slow infusion at a rate of 0.2-0.3 mg/min for super-selective contact thrombolysis, with a duration of 15 minutes. For patients with a body weight \>80 kg, the infusion rate will be limited to 0.2 mg/min for 15 minutes.
DRUG	standard medical management	Patients will receive standard medical management as recommended by current guidelines# #《Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke (2023)》and《Chinese Guidelines for Secondary Prevention of Ischemic Stroke and Transient Ischemic Attack (2022)》

Timeline

• Start date: 2026-01-22
• Primary completion: 2027-09-30
• Completion: 2027-12-31
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

1 site across 1 country: China