NCT03805308

The TESLA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Mercy Health Ohio · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the trial is to establish the effectiveness of IAT (versus medical management) in patients with moderate-large infarcts (NCCT ASPECTS 2-5) at baseline, with adaptive enrichment to better define the upper limit of infarct volume for treatment eligibility. Furthermore, the investigators aim to determine whether certain subgroups of patients with large baseline infarcts will have a greater treatment benefit. Finally, the investigators will assess the agreement of ASPECTS scores between site investigators, the core imaging lab, and automated software.

Detailed description

Prospective, randomized, open-label, blinded endpoint study. Patients presenting with symptoms of AIS who have evidence of a moderate-large infarct volume (Non-contrast CT Alberta Stroke Program Early CT score \[NCCT ASPECTS\] 2-5 in the anterior circulation will be assigned to either best medical management alone (including IV rtPA) or intra-arterial treatment (IAT) with mechanical thrombectomy added to best medical management. Each treated patient will be followed and assessed for 3 months after randomization.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
PROCEDURE	Intra-arterial Therapy	Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels.

Timeline

• Start date: 2019-07-16
• Primary completion: 2023-02-25
• Completion: 2023-11-18
• First posted: 2019-01-15
• Last updated: 2024-04-23

Locations

43 sites across 1 country: United States