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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorPenumbra Inc.

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

I.1. Patient age 18-80 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

Disqualifiers

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.

Trial population

Patients presenting with acute ischemic stroke (AIS) who are eligible for aspiration based mechanical thrombectomy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Penumbra System ®

    Device

    Neurovacular Mechanical Thrombectomy with the Penumbra System®

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Patients with acute ischemic stroke (AIS)1 intervention

Trial outcomes

Primary outcomes

1

Outcomes:

Angiographic revascularization of the occluded target vessel immediately post- procedure as defined by modified Thrombolysis in Cerebral Infarction (mTICI) 2b or higher Angiographic revascularization of the occluded target vessel immediately post- procedure as defined by mTICI 2c or higher * Angiographic revascularization of the occluded target vessel after the first pass as defined by mTICI 2b or higher * Angiographic revascularization of the occluded target vessel after the first pass as defined by mTICI 2c or higher

Time frame
It is anticipated this study will take approximately 2 years. All participants will be followed for approximately 90-day or to outcome (e.g., withdrawal, death), whichever occurs first.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.