NCT03464565

COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 650 (actual)
• Sponsor: Penumbra Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this registry is to collect performance and safety data on the Penumbra System including the 3D Revascularization Device in a real world patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).

Detailed description

Registry Objective: The primary objective of this registry is to collect real-world performance and safety data on Penumbra System including the 3D Revascularization Device in a patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO). Registry Design: This will be a prospective, single-arm, multi-center observational registry and will include patients that present with either anterior or posterior LVO who are eligible for mechanical thrombectomy using the Penumbra System. Registry Duration: Subjects will be in the registry for approximately 90 days from enrollment to last follow-up.

Conditions

• Stroke, Ischemic

Interventions

Type	Name	Description
DEVICE	Penumbra System	Penumbra System

Timeline

• Start date: 2018-07-02
• Primary completion: 2020-01-17
• Completion: 2020-01-17
• First posted: 2018-03-14
• Last updated: 2020-12-22

Locations

42 sites across 6 countries: United States, France, Germany, Poland, Russia, Spain

Regulatory

• FDA-regulated device study