Status:
COMPLETED
COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device
Lead Sponsor:
Penumbra Inc.
Conditions:
Stroke, Ischemic
Eligibility:
All Genders
18+ years
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 (A...
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 2 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 17 2020
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT03464565
Start Date
July 2 2018
End Date
January 17 2020
Last Update
December 22 2020
Active Locations (42)
Enter a location and click search to find clinical trials sorted by distance.
1
Banner Desert Medical Center
Mesa, Arizona, United States, 85202
2
Eden Medical Center
Castro Valley, California, United States, 94546
3
St. Jude Medical Center
Fullerton, California, United States, 92835
4
Cedar Sinai Medical Center
Los Angeles, California, United States, 90048