Trials / Completed
CompletedNCT01793792
Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)
Pivotal Study of the Microvention, Inc Neurovascular Self-Expanding Retrievable Stent System LVIS
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 153 (actual)
- Sponsor
- Microvention-Terumo, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of the Low Profile Visualized Intraluminal Support(LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of wide-necked intracranial aneurysms with coils.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LVIS™ and LVIS™ Jr | The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms. |
Timeline
- Start date
- 2013-07-01
- Primary completion
- 2015-11-01
- Completion
- 2016-01-01
- First posted
- 2013-02-18
- Last updated
- 2025-06-22
- Results posted
- 2019-11-27
Locations
21 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01793792. Inclusion in this directory is not an endorsement.