NCT05172934

Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy Pilot Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: ProMedica Health System · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Prospective, single center, non-randomized, pilot study to assess the feasibility of IA TNK following standard of care mechanical thrombectomy (MT) in patients with AIS. Participants will receive IA TNK after achieving mTICI 2b or 2c reperfusion with standard of care MT. Patients enrolled into the study will be followed for 3 months after treatment with IA TNK.

Detailed description

As current MT technology is not amenable to retrieval of distal occlusions (M3/M4, etc), we hypothesize that IA lytic may play an important role as an adjunctive therapy to open up distal vessels (after the primary LVO has been removed) to achieve complete or near complete reperfusion. In this pilot trial, our goal is to assess the feasibility and safety of IA Tenecteplase (TNK) as an adjunctive therapy following standard of care mechanical thrombectomy (MT) in patients with AIS. A total of 20 patients will be enrolled into the ALLY pilot study.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	intra-arterial tenecteplase	intra-arterial drug administered after mechanical thrombectomy

Timeline

• Start date: 2022-03-15
• Primary completion: 2023-09-12
• Completion: 2023-11-01
• First posted: 2021-12-29
• Last updated: 2025-03-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study