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NCT01541254 · ClinicalTrials.gov registry record · Phase 2
Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device
A Phase 2 study of Intracranial Aneurysms, sponsored by Microvention-Terumo.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 6
- Study locations
NCT01541254: Completed Phase 2 study of Intracranial Aneurysms, sponsored by Microvention-Terumo.
NCT01541254 is a Phase 2 study of Intracranial Aneurysms that has completed, run by Microvention-Terumo. The registered enrollment target is 30 participants, below the 43-participant average among 4 other Intracranial Aneurysms trials with a reported enrollment target (30% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01541254, a Phase 2 study of Intracranial Aneurysms, has completed, sponsored by Microvention-Terumo.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and probable benefit of the Low-profile Visualized Intraluminal Support (LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of unruptured wide-neck intracranial aneurysms with bare platinum embolization coils.
Primary Outcome
Imaging from each subject to be reviewed by an independent core lab who will be comparing with baseline and post procedure images.
Conditions Studied
Interventions
- DEVICE Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
Study Locations (6)
New York
- Albany Medical College - Albany
- Stony Brook University Medical Center - Stony Brook
Texas
- UT Southwestern - Dallas
- Methodist Hospital - Houston
Pennsylvania
- Thomas Jefferson Hospital - Philadelphia
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
What the finished NCT01541254 record still lists
NCT01541254 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 43-participant average among 4 other Intracranial Aneurysms trials with a reported enrollment target (30% lower).
The record links to 1 condition, with Intracranial Aneurysms appearing as the primary indexed condition, and to 1 intervention - of which Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.) is the first listed.
NCT01541254 lists 6 locations in 4 states (New York, Texas, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT01541254 about?
NCT01541254 is a clinical study titled "Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device". The purpose of this study is to evaluate the safety and probable benefit of the Low-profile Visualized Intraluminal Support (LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of unruptured wide-neck intracranial aneurysms with bare platinum embolization...
What is the current status of trial NCT01541254?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2012-03. Estimated completion is 2013-06.
What conditions does trial NCT01541254 study?
This clinical trial studies the following conditions: Intracranial Aneurysms.
What interventions are being tested in trial NCT01541254?
The interventions under investigation include: Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.) (DEVICE).
Who is sponsoring clinical trial NCT01541254?
This trial is sponsored by Microvention-Terumo, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01541254 being conducted?
This trial has 6 study locations across New York, Pennsylvania, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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