Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)

• Sponsor: Microvention-Terumo, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01793792
• Collaborator: (none)
• Enrollment: 153
• Locations: 21
• Arm: 1
• Duration (Months): 30
• Patients Per Site: 7.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Aneurysms	Device: LVIS™ and LVIS™ Jr	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 153 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Low Profile Visualized Intraluminal Support deviceLow Profile Visualized Intraluminal Support device
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pivotal Study of the Microvention, Inc Neurovascular Self-Expanding Retrievable Stent System LVIS
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Device: LVIS The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms. Device: LVIS™ and LVIS™ Jr. MicroVention Low-profile Visualized Intraluminal Support Device	Device: LVIS™ and LVIS™ Jr; The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.; Other Names: Low Profile Visualized Intraluminal Support device

Outcome Measures

Primary Outcome Measures

1. Primary Effectiveness Composite Success "Number of Participants With Primary Effectiveness Composite Success (100% Aneurysm Occlusion Without Clinically Significant In-stent Stenosis or Target Aneurysm Retreatment" [12 months]

2. Primary Safety Composite Rate (Disabling Stroke With mRS Score Greater Than or Equal to 3, or Neurological Death Within 12 Months [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject age between 18 and 75 years

• Subject with an unruptured or ruptured(>30days since occurence), wide-necked (neck ≥4mm or dome to neck ratio <2)intracranial saccular aneurysm (<20mm maximum diameter in any plane)

Exclusion Criteria:

• Subject with significant extra or intracranial stenosis of the parent artery (>50%) proximal to the target aneurysm.

• Subject with any condition which in the opinion of the treating physician would place the subject at high risk of embolic stroke

• Subject with contraindications to the use of antiplatelet agents

• Subject who is unable to complete the required follow-up

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Joseph's Hospital and Medical Center	Phoenix	Arizona	United States	85013
2	Dignity Health/Mercy San Juan Medical Center	Carmichael	California	United States	95608
3	Colorado Neurological Institute	Englewood	Colorado	United States	80113
4	Rush University Medical Center	Chicago	Illinois	United States	60612
5	Advocate Health and Hospital	Oak Lawn	Illinois	United States	60453
6	Indiana University/Methodist Research Institute	Indianapolis	Indiana	United States	46202
7	University of Maryland	Baltimore	Maryland	United States	21201
8	Tufts Medical Center	Boston	Massachusetts	United States	02111
9	Abbott Northwestern Hospital	Minneapolis	Minnesota	United States	55407
10	University of Minnesota	Minneapolis	Minnesota	United States	55455
11	Albany Medical College	Albany	New York	United States	12208
12	University at Buffalo Neurosurgery	Buffalo	New York	United States	14203
13	North Shore University Hospital	Manhasset	New York	United States	11030
14	St. Luke's Roosevelt Hospital Center	New York	New York	United States	10019
15	Stony Brook University Medical Center	Stony Brook	New York	United States	11794
16	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
17	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15219
18	Medical University of South Carolina	Charleston	South Carolina	United States	29425
19	Methodist University Hospital	Memphis	Tennessee	United States	38120
20	Vanderbilt University	Nashville	Tennessee	United States	37232
21	The Methodist Hospital	Houston	Texas	United States	77030

Sponsors and Collaborators

• Microvention-Terumo, Inc.

Investigators

• Principal Investigator: David Fiorella, M.D., Stony Brook University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• The safety and effectiveness of the LVIS stent system for the treatment of wide-necked cerebral aneurysms: final results of the pivotal US LVIS trial. Fiorella D, Boulos A, Turk AS, Siddiqui AH, Arthur AS, Diaz O, Lopes DK on behalf of LVIS Investigators

Publications

None provided.

• Responsible Party: Microvention-Terumo, Inc.
• ClinicalTrials.gov Identifier: NCT01793792
• Other Study ID Numbers: CL11002; G110188/S004
• First Posted: Feb 18, 2013
• Last Update Posted: Nov 27, 2019
• Last Verified: Nov 1, 2019

• Keywords provided by Microvention-Terumo, Inc.: intracranial, saccular, aneurysms, stenting, coiling
• Additional relevant MeSH terms: Intracranial Aneurysm; Aneurysm

Study Results

Participant Flow

Arm/Group Title	Device: LVIS
Arm/Group Description	Device: LVIS™ and LVIS™ Jr. MicroVention Low-profile Visualized Intraluminal Support Device
Period Title: Overall Study
STARTED	153
Treated	153
COMPLETED	141
NOT COMPLETED	12

Baseline Characteristics

Arm/Group Title	Device: LVIS
Arm/Group Description	LVIS™ and LVIS™ Jr: The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.
Overall Participants	153
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	58.3 (10.49)
Sex: Female, Male (Count of Participants)
Female	110 71.9%
Male	43 28.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.7%
Asian	2 1.3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	24 15.7%
White	123 80.4%
More than one race	2 1.3%
Unknown or Not Reported	1 0.7%

Outcome Measures

1. Primary Outcome

Title	Primary Effectiveness Composite Success "Number of Participants With Primary Effectiveness Composite Success (100% Aneurysm Occlusion Without Clinically Significant In-stent Stenosis or Target Aneurysm Retreatment"
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device: LVIS
Arm/Group Description	Device: LVIS™ and LVIS™ Jr. MicroVention Low-profile Visualized Intraluminal Support Device
Measure Participants	153
Count of Participants [Participants]	108 70.6%

2. Primary Outcome

Title	Primary Safety Composite Rate (Disabling Stroke With mRS Score Greater Than or Equal to 3, or Neurological Death Within 12 Months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device: LVIS
Arm/Group Description	Device: LVIS™ and LVIS™ Jr. MicroVention Low-profile Visualized Intraluminal Support Device
Measure Participants	153
Count of Participants [Participants]	9 5.9%

Adverse Events

Time Frame	1 year
Arm/Group Title	Device: LVIS
Arm/Group Description	LVIS™ and LVIS™ Jr: The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.
All Cause Mortality
	Device: LVIS
	Affected / at Risk (%)	# Events
Total	6/153 (3.9%)
Serious Adverse Events
	Device: LVIS
	Affected / at Risk (%)	# Events
Total	48/153 (31.4%)
Eye disorders
Visual impairment	4/153 (2.6%)	5
Nervous system disorders
Aneurysm rupture	4/153 (2.6%)	4
Aphasia	1/153 (0.7%)	1
Dissection or perforation of the parent artery	1/153 (0.7%)	1
Hydrocephalus	1/153 (0.7%)	1
Intra-Parenchymal Hemorrhage (IPH)	4/153 (2.6%)	4
Neurological deficits	3/153 (2%)	3
Seizure	3/153 (2%)	4
Stent Thrombosis	5/153 (3.3%)	5
Stroke	9/153 (5.9%)	11
Sub-Arachnoid Hemorrhage (SAH)	3/153 (2%)	3
Sub-Dural Hematoma (SDH)	3/153 (2%)	3
TIA (Transient Ischemic Attack)	5/153 (3.3%)	5
Thromboembolic event	1/153 (0.7%)	1
Vasospasm	7/153 (4.6%)	7
Surgical and medical procedures
Target aneurysm retreatment	5/153 (3.3%)	5
Other (Not Including Serious) Adverse Events
	Device: LVIS
	Affected / at Risk (%)	# Events
Total	15/153 (9.8%)
Nervous system disorders
Headache	15/153 (9.8%)	17

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.