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Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device (LVIS)

Primary Purpose

Intracranial Aneurysms

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
Sponsored by
Microvention-Terumo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysms focused on measuring intracranial aneurysm, wide-neck, saccular, endovascular treatment, coil embolization, stent, bare platinum

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Albany Medical College
  • Stony Brook University Medical Center
  • Thomas Jefferson Hospital
  • Medical University of South Carolina
  • UT Southwestern
  • Methodist Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Parent Artery Patency Measured Angiographically at 6 Months
To be assessed by Independent Core Lab.
Successful Delivery of the LVIS™ Device Measures by Technical Success
Technical success being defined as: access to the lesion, successful deployment of the LVIS™ device.
Significant Stenosis(>50%) of the Treated Artery at 6 Months
Parent Artery will be measured baseline and compared at 6 months post procedure per review by the Independent Core Lab.
Stent Migration at 6 Months
Angiographic images will be comparing post procedure sent position to 6 months
Device and Procedure Related Serious Adverse Events
All Serious Adverse events will be reported per protocol
Unplanned Embolization Coiling Within 6 Months
If the target lesion(aneurysm)treated needed further embolization within 6 months of initial treatment(detected during follow up or unscheduled visit ),data will be recorded and analyzed.

Full Information

First Posted
February 15, 2012
Last Updated
September 6, 2014
Sponsor
Microvention-Terumo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01541254
Brief Title
Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device
Acronym
LVIS
Official Title
A Feasibility Study of the MicroVention,Inc.(LVIS™) Neurovascular Self-Expanding Retrievable Stent System in the Treatment of Wide-Necked Intracranial Artery Aneurysms
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Microvention-Terumo, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
With the stent-assisted technique to treat wide neck intracranial aneurysms, the neurovascular stent is placed across the aneurysm neck, to act as a bridge to prevent coils from protruding into the parent artery. Stenting may allow to more safely achieve a higher packing density of coils. These effects may improve the rates of complete aneurysm occlusion and enhance the durability of the coiling treatment.The LVIS™ device manufactured by MicroVention, Inc. has a braided design which may provide superior conformability and parent artery apposition, as well as a more reliable continuous and uniform neck bridging than other neurovascular stents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysms
Keywords
intracranial aneurysm, wide-neck, saccular, endovascular treatment, coil embolization, stent, bare platinum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Other
Arm Description
Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
Intervention Type
Device
Intervention Name(s)
Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
Other Intervention Name(s)
Low-profile Vizualized Intraluminal Support Device
Intervention Description
Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
Primary Outcome Measure Information:
Title
Probable Benefit Measures as Successful Aneurysm Treatment With the LVIS™ Device, as Measured by Aneurysm Angiographic Occlusion of ≥ 90% at 6 Months (± 4 Weeks)
Description
Imaging from each subject to be reviewed by an independent core lab who will be comparing with baseline and post procedure images.
Time Frame
6 months ± 4 weeks
Title
Safety Measures as Any Major Stroke or Death Within 30 Days, or Major Ipsi-lateral Stroke or Neurological Death Within 6 Months
Description
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.
Time Frame
30 days-6 months
Secondary Outcome Measure Information:
Title
Parent Artery Patency Measured Angiographically at 6 Months
Description
To be assessed by Independent Core Lab.
Time Frame
6 months
Title
Successful Delivery of the LVIS™ Device Measures by Technical Success
Description
Technical success being defined as: access to the lesion, successful deployment of the LVIS™ device.
Time Frame
24 hours
Title
Significant Stenosis(>50%) of the Treated Artery at 6 Months
Description
Parent Artery will be measured baseline and compared at 6 months post procedure per review by the Independent Core Lab.
Time Frame
6 months
Title
Stent Migration at 6 Months
Description
Angiographic images will be comparing post procedure sent position to 6 months
Time Frame
6 months
Title
Device and Procedure Related Serious Adverse Events
Description
All Serious Adverse events will be reported per protocol
Time Frame
Day 1-6months(± 4 months)
Title
Unplanned Embolization Coiling Within 6 Months
Description
If the target lesion(aneurysm)treated needed further embolization within 6 months of initial treatment(detected during follow up or unscheduled visit ),data will be recorded and analyzed.
Time Frame
Day 1-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Fiorella, M.D., Ph.D.
Organizational Affiliation
Stony Brook University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Thomas Jefferson Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
UT Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26391016
Citation
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.
Results Reference
derived

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Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device

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