COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device
- Conditions
- Stroke, Ischemic
- Registration Number
- NCT03464565
- Lead Sponsor
- Penumbra Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 650
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.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.All-cause mortality at 90 days 90 days All-cause mortality at 90 days
- Secondary Outcome Measures
Name Time Method 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 Time to Revascularization During Procedure Occurrence of symptomatic intracranial hemorrhages (sICH) 24 Hours Post Procedure 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
Length of hospital stay Through discharge, up to study completion at approximately 90 days
Trial Locations
- Locations (42)
Banner Desert Medical Center
🇺🇸Mesa, Arizona, United States
Eden Medical Center
🇺🇸Castro Valley, California, United States
St. Jude Medical Center
🇺🇸Fullerton, California, United States
Cedar Sinai Medical Center
🇺🇸Los Angeles, California, United States
Mercy San Juan Medical Center
🇺🇸Sacramento, California, United States
Los Robles Hospital
🇺🇸Thousand Oaks, California, United States
RIA
🇺🇸Englewood, Colorado, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Naples Community Hospital
🇺🇸Naples, Florida, United States
Scroll for more (32 remaining)Banner Desert Medical Center🇺🇸Mesa, Arizona, United States