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NCT04157270 · ClinicalTrials.gov registry record
LOTUS: Global Acute Stroke Study Utilizing Penumbra System
A clinical trial, sponsored by Penumbra.
- Terminated
- Registry status
- 23
- Enrollment target
NCT04157270: Clinical Trial study, sponsored by Penumbra.
NCT04157270 is a clinical trial that was terminated before completion, run by Penumbra. The registered enrollment target is 23 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04157270 was terminated before completion, sponsored by Penumbra.
- TERMINATED
- Registry status
- 23 participants
- Enrollment target
Study Summary
The primary objective of this study is to demonstrate safety and effectiveness of the Penumbra System in a population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).
Primary Outcome
Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a modified treatment in cerebral infarction (mTICI) score of 2b or higher. mTICI scale ranges from 0 to 3 with higher values representing better outcomes.
Interventions
- DEVICE Penumbra System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2020-01-12 |
| Est. Completion | 2021-05-10 |
Why NCT04157270 stopped before completion
NCT04157270 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 23 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Penumbra System is the first listed.
NCT04157270 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04157270 about?
NCT04157270 is a clinical study titled "LOTUS: Global Acute Stroke Study Utilizing Penumbra System". The primary objective of this study is to demonstrate safety and effectiveness of the Penumbra System in a population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).
What is the current status of trial NCT04157270?
This trial is currently terminated. The enrollment target is 23 participants. The study started on 2020-01-12. Estimated completion is 2021-05-10.
What interventions are being tested in trial NCT04157270?
The interventions under investigation include: Penumbra System (DEVICE).
Who is sponsoring clinical trial NCT04157270?
This trial is sponsored by Penumbra, which has 25 total clinical trials registered on ClinicalTrials.gov.
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