Penumbra System
DevicePenumbra System
NCT Number: NCT03464565
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).
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Notify Me18 year and older
All sexes
Observational
CHU de Bordeaux - Hôpital Pellegrin, Bordeaux, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Penumbra System
Time frame: 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.
Time frame: 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.
Time frame: 90 days
All-cause mortality at 90 days
Time frame: Within 24 hours of procedure
Time frame: During Procedure
Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure
Time frame: 24 Hours Post Procedure
Time frame: During Procedure
Time frame: Through discharge, up to study completion at approximately 90 days
Time frame: Through discharge, up to study completion at approximately 90 days
Penumbra Inc.
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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