Trial Outcomes & Findings for Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device (NCT NCT01541254)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

30 participants

Primary outcome timeframe

6 months ± 4 weeks

Results posted on

2025-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.) Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.): Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
Overall Study STARTED	36
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.) Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.): Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
Overall Study Withdrawal by Subject	1
Overall Study excluded - metal allergy	1
Overall Study enrolled after study closed	1
Overall Study GI bleed prior to procedure	1
Overall Study stent not required	1
Overall Study alternate stent used	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=31 Participants Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
Age, Continuous	58.6 years STANDARD_DEVIATION 10.6 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm n=28 Participants Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
Probable Benefit Measures as Successful Aneurysm Treatment With the LVIS™ Device, as Measured by Aneurysm Angiographic Occlusion of ≥ 90% at 6 Months (± 4 Weeks)	95 percent occlusion of aneurysm Standard Deviation 19

PRIMARY outcome

Timeframe: 30 days-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.

Outcome measures

Outcome measures
Measure	Single Arm n=31 Participants Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
Safety Measures as Any Major Stroke or Death Within 30 Days, or Major Ipsi-lateral Stroke or Neurological Death Within 6 Months	0 patients Interval 0.0 to 9.2

SECONDARY outcome

Timeframe: 6 months

To be assessed by Independent Core Lab.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Technical success being defined as: access to the lesion, successful deployment of the LVIS™ device.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Parent Artery will be measured baseline and compared at 6 months post procedure per review by the Independent Core Lab.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Angiographic images will be comparing post procedure sent position to 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1-6months(± 4 months)

All Serious Adverse events will be reported per protocol

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1-6 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.

Outcome measures

Outcome data not reported

Adverse Events

Single Arm

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm n=31 participants at risk Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
General disorders Stroke/TIA	3.2% 1/31

Other adverse events

Other adverse events
Measure	Single Arm n=31 participants at risk Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
General disorders Headache	25.8% 8/31
General disorders Hematoma at access site	6.5% 2/31
General disorders Stroke or TIA	6.5% 2/31
General disorders Nausea	6.5% 2/31
Infections and infestations Infection	6.5% 2/31

Additional Information

Mary Schmitz

MicroVention, Inc.

Phone: 714-247-8025

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee As part of a multi-center study the results of the national Trial shall be published by a National Principal Investigator within 12 months of completion of last study site. If no publication within that time frame, Principal Investigator is free to publish. Copies of proposed publication must be submitted to Sponsor at least 30 days in advance to ensure removal of proprietary or confidential information.
Publication restrictions are in place

Restriction type: OTHER