Stroke, Ischemic
Conditions
Keywords
Large Vessel Occlusion, Acute Ischemic Stroke, Mechanical Thrombectomy, Penumbra System, 3D Revascularization
Brief 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.
Interventions
DEVICEPenumbra System
Penumbra System
Sponsors
Penumbra Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mTICI Score | Post Procedure | Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a modified treatment in cerebral infarction (mTICI) score 2b or higher. mTICI scale ranges 0 to 3 higher values represent better outcomes. |
| Functional Subject Outcome | 90 days post | Functional subject outcome at 90 days post-procedure as defined by a modified Rankin Scale (mRS) 0-2. mRS scale ranges 0 to 6 higher values represent a worse outcome. |
| All-cause mortality at 90 days | 90 days | All-cause mortality at 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Revascularization | During Procedure | — |
| Incidence of device and procedure related Serious Adverse Events (SAEs) | Within 24 hours of procedure | — |
| Discharge Facility | Through discharge, up to study completion at approximately 90 days | — |
| Length of hospital stay | Through discharge, up to study completion at approximately 90 days | — |
| Occurrence of embolization in previously uninvolved (or new) territories (ENT) | During Procedure | Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure |
| Occurrence of symptomatic intracranial hemorrhages (sICH) | 24 Hours Post Procedure | — |
Countries
France, Germany, Poland, Russia, Spain, United States
Outcome results
None listed