NCT01541254

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 29, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 15, 2014

Completed
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

1.3 years

First QC Date

February 15, 2012

Results QC Date

September 5, 2014

Last Update Submit

June 13, 2025

Conditions

Intracranial Aneurysms

Keywords

intracranial aneurysmwide-necksaccularendovascular treatmentcoil embolizationstentbare platinum

Outcome Measures

Primary Outcomes (2)

  • Probable Benefit Measures as Successful Aneurysm Treatment With the LVIS™ Device, as Measured by Aneurysm Angiographic Occlusion of ≥ 90% at 6 Months (± 4 Weeks)

    Imaging from each subject to be reviewed by an independent core lab who will be comparing with baseline and post procedure images.

    6 months ± 4 weeks

  • Safety Measures as Any Major Stroke or Death Within 30 Days, or Major Ipsi-lateral Stroke or Neurological Death Within 6 Months

    A major stroke is defined as a new neurological event that persists for \>24 hours and results in a ≥ 4 point increase in the National Institutes of Health Stroke Scale (NIHSS) score compared to baseline or compared to any subsequent lower score.

    30 days-6 months

Secondary Outcomes (6)

  • Parent Artery Patency Measured Angiographically at 6 Months

    6 months

  • Successful Delivery of the LVIS™ Device Measures by Technical Success

    24 hours

  • Significant Stenosis(>50%) of the Treated Artery at 6 Months

    6 months

  • Stent Migration at 6 Months

    6 months

  • Device and Procedure Related Serious Adverse Events

    Day 1-6months(± 4 months)

  • +1 more secondary outcomes

Study Arms (1)

Single Arm

OTHER

Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)

Device: Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)

Interventions

Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)DEVICE

Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)

Also known as: Low-profile Vizualized Intraluminal Support Device
Single Arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject whose age is between 18 and 80 years old
  • Subject with unruptured wide neck, saccular,intracranial aneurysm, \< 20mm maximum diameter in any plane ( wide neck defined as neck width ≥ 4mm or dome to-neck ratio \< 2).
  • Subject's aneurysm arises from a parent vessel with a diameter of ≥ 2.5m and ≤ 4.5mm.
  • Subject or his/her legally authorized representative understands the nature of the procedure and provides signed informed consent form.
  • Subject is willing to return to the investigational site for the 30- day and 6-month follow-up evaluations

You may not qualify if:

  • Subject who presents with ruptured aneurysm, unless rupture occured 30 days or more prior to screening.
  • Subject who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region.
  • Subject with an International Normalized Ratio (INR)≥ 1.5
  • Subject with serum creatinine level \>2mg/dl at time of enrollment
  • Subject with known allergies to nickel-titanium metal
  • Subject with known allergies to aspirin, heparin, ticlopidine, or clopidogrel
  • Subject with a life threatening allergy to contrast(unless treatment for allergy is tolerated)
  • Subject who has a known cardiac disorder, likely to be associated with cardioembolic symptoms such as atrial fibrillation
  • Subject with any condition which in the opinion of the treating physician would place the subject at a high risk of embolic stroke
  • Subject who is currently participating in another clinical research study
  • Subject who has had a previous intracranial stenting procedure associated with the target aneurysm
  • Subject who is unable to complete the required follow-up
  • Subject who is pregnant or breastfeeding
  • Subject who has participated in a drug study within the last 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Albany Medical College

Albany, New York, 12208, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Thomas Jefferson Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Fiorella D, Arthur A, Boulos A, Diaz O, Jabbour P, Pride L, Turk AS, Woo HH, Derdeyn C, Millar J, Clifton A. Final results of the US humanitarian device exemption study of the low-profile visualized intraluminal support (LVIS) device. J Neurointerv Surg. 2016 Sep;8(9):894-7. doi: 10.1136/neurintsurg-2015-011937. Epub 2015 Sep 21.

    PMID: 26391016DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Mary Schmitz
Organization
MicroVention, Inc.
mary.schmitz@microvention.com
714-247-8025

Study Officials

  • David Fiorella, M.D., Ph.D.

    Stony Brook University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2012

First Posted

February 29, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

July 1, 2025

Results First Posted

September 15, 2014

Record last verified: 2025-06

Locations

US(6)