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

Penumbra

Status

Enrolling

Conditions

Acute Ischemic Stroke (AIS)

Treatments

Device: Penumbra System ®

Study type

Observational

Funder types

Industry

Identifiers

NCT07107022

CLP 30324

Details and patient eligibility

About

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)

Full description

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

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

I.1. Patient age 18-75 years
I.2. Pre-stroke mRS 0-1
I.3. Patients experiencing acute ischemic stroke who are eligible for mechanical thrombectomy using the Penumbra System
I.4. Frontline treatment with Penumbra System
I.5. Signed informed consent per Institution Review Board/Ethics Committee

Exclusion criteria

E.1. Alberta Stroke Program Early CT Score (ASPECTS) ≤6 (for anterior circulation strokes)
E.2. Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days
E.3. Currently participating in an investigational (drug, device, etc.) clinical trial that will influence the endovascular procedure or acute treatment of the patient. Patients in secondary prevention, observational, natural history, and/or
epidemiological studies are eligible.
E.4. Other medical, behavioral, or psychological conditions that in the opinion of the Investigator could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study