Trial Outcomes & Findings for Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support) (NCT NCT01793792)

NCT ID: NCT01793792

Last Updated: 2025-06-22

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 153 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-06-22

Participant Flow

Participant milestones

Measure	Device: LVIS Device: LVIS™ and LVIS™ Jr. MicroVention Low-profile Visualized Intraluminal Support Device
Overall Study STARTED	153
Overall Study Treated	153
Overall Study COMPLETED	141
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Measure	Device: LVIS Device: LVIS™ and LVIS™ Jr. MicroVention Low-profile Visualized Intraluminal Support Device
Overall Study Death	5
Overall Study Lost to Follow-up	5
Overall Study Withdrawal by Subject	1
Overall Study Device Not Implanted	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Device: LVIS n=153 Participants LVIS™ and LVIS™ Jr: The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.
Age, Continuous	58.3 Years STANDARD_DEVIATION 10.49 • n=93 Participants
Sex: Female, Male Female	110 Participants n=93 Participants
Sex: Female, Male Male	43 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	24 Participants n=93 Participants
Race (NIH/OMB) White	123 Participants n=93 Participants
Race (NIH/OMB) More than one race	2 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Device: LVIS n=153 Participants Device: LVIS™ and LVIS™ Jr. MicroVention Low-profile Visualized Intraluminal Support Device
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"	108 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Device: LVIS n=153 Participants Device: LVIS™ and LVIS™ Jr. MicroVention Low-profile Visualized Intraluminal Support Device
Primary Safety Composite Rate (Disabling Stroke With mRS Score Greater Than or Equal to 3, or Neurological Death Within 12 Months	9 Participants

Adverse Events

Device: LVIS

Serious events: 48 serious events

Other events: 15 other events

Deaths: 6 deaths

Serious adverse events

Measure	Device: LVIS n=153 participants at risk LVIS™ and LVIS™ Jr: The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.
Nervous system disorders Aneurysm rupture	2.6% 4/153 • Number of events 4 • 1 year
Nervous system disorders Aphasia	0.65% 1/153 • Number of events 1 • 1 year
Nervous system disorders Dissection or perforation of the parent artery	0.65% 1/153 • Number of events 1 • 1 year
Nervous system disorders Hydrocephalus	0.65% 1/153 • Number of events 1 • 1 year
Nervous system disorders Intra-Parenchymal Hemorrhage (IPH)	2.6% 4/153 • Number of events 4 • 1 year
Nervous system disorders Neurological deficits	2.0% 3/153 • Number of events 3 • 1 year
Nervous system disorders Seizure	2.0% 3/153 • Number of events 4 • 1 year
Nervous system disorders Stent Thrombosis	3.3% 5/153 • Number of events 5 • 1 year
Nervous system disorders Stroke	5.9% 9/153 • Number of events 11 • 1 year
Nervous system disorders Sub-Arachnoid Hemorrhage (SAH)	2.0% 3/153 • Number of events 3 • 1 year
Nervous system disorders Sub-Dural Hematoma (SDH)	2.0% 3/153 • Number of events 3 • 1 year
Nervous system disorders TIA (Transient Ischemic Attack)	3.3% 5/153 • Number of events 5 • 1 year
Surgical and medical procedures Target aneurysm retreatment	3.3% 5/153 • Number of events 5 • 1 year
Nervous system disorders Thromboembolic event	0.65% 1/153 • Number of events 1 • 1 year
Nervous system disorders Vasospasm	4.6% 7/153 • Number of events 7 • 1 year
Eye disorders Visual impairment	2.6% 4/153 • Number of events 5 • 1 year

Other adverse events

Measure	Device: LVIS n=153 participants at risk LVIS™ and LVIS™ Jr: The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.
Nervous system disorders Headache	9.8% 15/153 • Number of events 17 • 1 year

Additional Information

Anne Hurley

MicroVention, Inc

Phone: 714-247-8000

Email: anne.hurley@microvention.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place