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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 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.

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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.

Conditions Studied

Intracranial Aneurysms

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

FieldValue
Enrollment Target 30 participants
Start Date 2012-03
Est. Completion 2013-06
Phase Phase 2

Sponsor

Microvention-Terumo

9 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01541254

The ClinicalTrials.gov registry entry for NCT01541254 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 43-participant average among 4 other Intracranial Aneurysms trials with a reported enrollment target (30% lower). The listed sponsor is Microvention-Terumo, which has 9 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 4 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.