NCT07107022

Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Acute Ischemic Stroke (AIS).

i-RISE: International Acute Ischemic Stroke Study With the Penumbra System®

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Penumbra Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to collect real-world performance and safety data on the Penumbra System in a patient population with acute ischemic stroke (AIS)

Detailed description

Post-market, real-world, prospective, single-arm, multi-center study that will enroll up to 200 participants at up to 15 sites globally

Conditions

• Acute Ischemic Stroke (AIS)

Interventions

Type	Name	Description
DEVICE	Penumbra System ®	Neurovacular Mechanical Thrombectomy with the Penumbra System®

Timeline

• Start date: 2025-11-01
• Primary completion: 2027-10-01
• Completion: 2027-12-01
• First posted: 2025-08-06
• Last updated: 2026-04-02

Locations

9 sites across 4 countries: Australia, France, Germany, Switzerland

Regulatory

• FDA-regulated device study