Trial Outcomes & Findings for Evaluation of the Technical Success of IVUS Guided VCF Placement Using the LUMIFI™ With Crux® VCF System (NCT NCT02394912)

Results Overview

All Subjects, Cohort A and Cohort B were included in the safety analysis. The primary endpoint of effectiveness, defined as technical success included only subjects within Cohort B. Technical success of filter placement is defined as the primary deployment of the filter such that the investigator judges the location to be suitable to provide sufficient mechanical protection against pulmonary embolism. Due to early stoppage of the study, enrollment of 100 subjects required to test the null hypothesis and evaluate the Primary Endpoint of Technical Success was not achieved. Therefore, a formal analysis of Technical Success was not performed.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

Day 1

Results posted on

2019-07-30

Participant Flow

This was a prospective, single-arm, multicenter clinical study to evaluate the safety \& effectiveness of the LUMIFI with Crux VCF system. The study included enrollment into a roll-in phase Cohort A consisting of 2 subjects/ site to assure compliance with the Investigational Device prior to enrolling into Cohort B, the treatment phase.

Participant milestones

Participant milestones
Measure	LUMIFI With Crux VCF System vena cava filter implantation (LUMIFI with Crux VCF System). Includes both Cohort A and Cohort B subjects.
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Technical Success of IVUS Guided VCF Placement Using the LUMIFI™ With Crux® VCF System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LUMIFI With Crux VCF System n=21 Participants vena cava filter implantation (LUMIFI with Crux VCF System)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

All Subjects, Cohort A and Cohort B were included in the safety analysis. The primary endpoint of effectiveness, defined as technical success included only subjects within Cohort B. Technical success of filter placement is defined as the primary deployment of the filter such that the investigator judges the location to be suitable to provide sufficient mechanical protection against pulmonary embolism. Due to early stoppage of the study, enrollment of 100 subjects required to test the null hypothesis and evaluate the Primary Endpoint of Technical Success was not achieved. Therefore, a formal analysis of Technical Success was not performed.

Outcome measures

Outcome measures
Measure	LUMIFI With Crux VCF System n=21 Participants vena cava filter implantation (LUMIFI with Crux VCF System)	Cohort A n=8 Participants Roll-in phase consisting of 2 subjects per site to assure compliance with use of the Investigational Device	Cohort B n=13 Participants Subjects are enrolled into Cohort B after each site has enrolled 2 subjects in Cohort A to assure compliance with use of the Investigational Device
Technical Success Rate	16 Participants	6 Participants	10 Participants

Adverse Events

LUMIFI With Crux VCF System

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	LUMIFI With Crux VCF System n=21 participants at risk vena cava filter implantation (LUMIFI with Crux VCF System)
Vascular disorders Pulmonary Emboli Bilaterial	4.8% 1/21 • Number of events 1
Vascular disorders Filter deployed too low	4.8% 1/21 • Number of events 1

Additional Information

VP Clinical Trials

Volcano

Phone: 858-720-8731

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Principal Investigator shall have the right to publish or otherwise make public any data resulting from the study upon the earlier of (a) publication of a multi-center publication (or any publication, if the Study is not a multi-center study) coordinated by Sponsor with respect to the data resulting from the study, and (b) eighteen (18) months after the Study is completed at all participating sites if a multi-center publication.
Publication restrictions are in place

Restriction type: OTHER