NCT05437055

THUNDER: Acute Ischemic Stroke Study with the Penumbra System® Including Thunderbolt™ Aspiration Tubing

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Penumbra Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to demonstrate the safety and efficacy of the Penumbra System including Thunderbolt Aspiration Tubing (Thunderbolt) in a population presenting with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO) who are eligible for mechanical thrombectomy.

Conditions

• Acute Ischemic Stroke
• Large Vessel Occlusion

Interventions

Type	Name	Description
DEVICE	Mechanical Thrombectomy (Penumbra System with Thunderbolt)	Subject will receive Penumbra System with Thunderbolt

Timeline

• Start date: 2022-08-11
• Primary completion: 2024-09-23
• Completion: 2024-12-10
• First posted: 2022-06-29
• Last updated: 2025-01-29

Locations

32 sites across 1 country: United States

Regulatory

• FDA-regulated device study