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

Penumbra

Status: Completed

Conditions: Stroke, Ischemic

Treatments: Device: Penumbra System

Study type: Observational

Funder types: Industry

Identifiers

NCT03464565

12965

Details and patient eligibility

About

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).

Full 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.

Enrollment: 650 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient age ≥ 18
• Pre-stroke mRS 0-1
• Patient experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System
• Planned frontline treatment with Penumbra System
• Signed informed consent per Institution Review Board/Ethics Committee

Exclusion criteria

• Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days.
• Currently participating in an investigational (drug, device, etc) clinical trial that will confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.

Trial design

650 participants in 1 patient group

Patients with acute ischemic stroke secondary to LVO

Treatment:

Device: Penumbra System